Soft suture anchor

ABSTRACT

A suture anchor assembly, adapted to be attached to a bone, that includes an anchor, which has an undeployed state in which it is soft and flexible, and which can be deployed into a deployed state which is compacted and hard, relative to the undeployed state, and defining a hold region, where the anchor is optimally held as the anchor is deployed. Also, one or more deployment strands are engaged into the anchor and extend out of the anchor, and wherein, when the anchor is in the undeployed state, holding the anchor at the hold region and pulling on the deployment strands compacts the anchor into the deployed state. Accordingly, the anchor can be introduced into a hole in bone and held in place at the hold region, as it is transformed into the deployed state by pulling on the deployment strands, thereby anchoring the anchor in the hole.

RELATED APPLICATIONS

This application is a continuation of patent application U.S. Ser. No.13/886,126 filed on May 2, 2013, which itself claims priority fromapplication Ser. No. 61/642,433, filed on May 3, 2012 and applicationSer. No. 61/642,733, filed on May 4, 2012 which are incorporated byreference as if fully set forth herein.

FIELD

This invention relates to suture systems and more particularly, to softsuture anchors for use in orthopedic surgical techniques.

BACKGROUND

Various orthopedic and other surgical techniques require the use of asuture anchor that engages bone. Common suture anchors are metal screwsthat have an eyelet at one end. The metal screws are driven into thebone. Suture is passed through the eyelet and is used to bring tissueinto contact with the bone for healing. Metal suture anchors pose anumber of associated risks, such as, but not limited to, bone fracture,anchor breakage and fragmentation, and anchor dislodgement.

Nonmetallic anchors are known, and typically take the form of softmaterial that is introduced into a hole that has been drilled into abone. The anchor is then partially retracted from the hole, and as theresult of friction against the side of the hole, bunches up to form acompact anchor as it is retracted, thereby holding to the hole andpreventing a complete retraction. Unfortunately, sometimes there isinsufficient friction to cause this to happen, and the anchor slips outof the hole, to no effect. Then, the process of attempting to set theanchor must be repeated, driving up time in surgery and possiblynecessitating the use of an additional suture anchor.

SUMMARY

In a first separate aspect, the present invention may take the form of asuture anchor assembly, adapted to be attached to a bone, that includesan anchor, which has an undeployed state in which it is soft andflexible, and which can be deployed into a deployed state which iscompacted and hard, relative to the undeployed state, and defining ahold region, where the anchor is optimally held as the anchor isdeployed. Also, one or more deployment strands are engaged into theanchor and extend out of the anchor, and wherein, when the anchor is inthe undeployed state, holding the anchor at the hold region and pullingon the deployment strands compacts the anchor into the deployed state.Accordingly, the anchor can be introduced into a hole in bone and heldin place at the hold region, as it is transformed into the deployedstate by pulling on the deployment strands, thereby anchoring the anchorin the hole.

In a second separate aspect, the present invention may take the form ofa method of attaching a suture to a bone, that uses an anchor that hasan undeployed state in which it is soft and flexible, and which can bedeployed into a deployed state which is compacted and hard, relative tothe undeployed state, and defining a hold region, where the anchor isoptimally held as the anchor is deployed. Also, one or more deploymentstrands are engaged into the anchor and extend out of the anchor, andwherein, when the anchor is in the undeployed state, holding the anchorat the hold region and pulling on the deployment strands compacts theanchor into the deployed state. In the method a pilot hole is in thebone and an insertion tool that is sized to push the suture into thepilot hole is provided. The hold region of the anchor is placed onto theinsertion tool and the insertion tool is used to push the anchor intothe pilot hole and to hold the anchor in place at the hold region, as itis transformed into the deployed state by pulling on the deploymentstrands, thereby anchoring the anchor in the hole.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 shows a side view of a suture in accordance with an embodiment;

FIG. 2 shows a side view of the suture of FIG. 1;

FIG. 3 shows a side view of a suture construct in accordance with anembodiment;

FIG. 4 shows a side view of a suture construct in accordance with anembodiment;

FIG. 5 shows a side view of a suture construct in accordance with anembodiment;

FIG. 6 shows a side view of a soft suture anchor in accordance with anembodiment;

FIG. 7 shows a side view of a suture construct in accordance with anembodiment;

FIG. 8 shows a side view of another soft suture anchor in accordancewith an embodiment;

FIG. 9 shows a side view of another soft suture anchor in accordancewith an embodiment;

FIG. 10 shows a side view of the soft suture anchor in accordance withthe embodiment of FIG. 9;

FIG. 11 shows a side view of the soft suture anchor in accordance withthe embodiment of FIG. 9 inserted into bone;

FIG. 12 shows a side view of the soft suture anchor in accordance withthe embodiment of FIG. 11 anchored into bone;

FIG. 13 shows a side view of another suture construct in accordance withan embodiment;

FIG. 14 shows a side view of another suture construct in accordance withan embodiment;

FIG. 15 shows a side view of another soft suture anchor in accordancewith an embodiment;

FIG. 16 shows a side view of the soft suture anchor in accordance withthe embodiment of FIG. 15;

FIG. 17 shows a side view of the soft suture anchor in accordance withthe embodiment of FIG. 15;

FIG. 18 shows a side view of the soft suture anchor in accordance withthe embodiment of FIG. 16 with the anchor inserted into bone;

FIG. 19 shows a side view of the soft suture anchor in accordance withthe embodiment of FIG. 18 anchored into bone;

FIG. 20 shows a side view of a suture in accordance with an embodiment;

FIG. 21 shows a side view of a suture construct in accordance with anembodiment;

FIG. 22 shows a side view of a suture construct in accordance with anembodiment;

FIG. 23 shows a side view of a suture construct in accordance with anembodiment;

FIG. 24 shows a side view of a suture construct in accordance with anembodiment;

FIG. 25 shows a side view of a suture construct in accordance with anembodiment;

FIG. 26 shows a side view of a suture construct in accordance with anembodiment;

FIG. 27 shows a side view of another soft suture anchor in accordancewith an embodiment;

FIG. 28 shows a side view of a suture construct in accordance with anembodiment;

FIG. 29 shows a side view of another soft suture anchor in accordancewith an embodiment;

FIG. 30 shows a side view of the soft suture anchor in accordance withthe embodiment of FIG. 29;

FIG. 31 shows a side view of the soft suture anchor in accordance withthe embodiment of FIG. 29;

FIG. 32 shows a side view of the soft suture anchor in accordance withthe embodiment of FIG. 29 with the anchor inserted into bone;

FIG. 33 shows a side view of the soft suture anchor in accordance withthe embodiment of FIG. 32 anchored into bone;

FIG. 34 shows a side view of a suture construct in accordance with anembodiment;

FIG. 35 shows a side view of a suture construct in accordance with anembodiment;

FIG. 36 shows a side view of another soft suture anchor in accordancewith an embodiment;

FIG. 37 shows a side view of the soft suture anchor in accordance withthe embodiment of FIG. 36;

FIG. 38 shows a side view of the soft suture anchor in accordance withthe embodiment of FIG. 36;

FIG. 39 shows a side view of the soft suture anchor in accordance withthe embodiment of FIG. 36 with the anchor inserted into bone;

FIG. 40 shows a side view of the soft suture anchor in accordance withthe embodiment of FIG. 39 anchored into bone;

FIG. 41 shows a side view of suture tape in accordance with anembodiment;

FIG. 42 shows a side view of a suture tape construct in accordance withan embodiment;

FIG. 43 shows a side view of a suture tape construct in accordance withan embodiment;

FIG. 44 shows a side view of a suture tape construct in accordance withan embodiment;

FIG. 45 shows a side view of a suture tape construct in accordance withan embodiment;

FIG. 46 shows a side view of a suture tape construct in accordance withan embodiment;

FIG. 47 shows a side view of a suture tape construct in accordance withan embodiment;

FIG. 48 shows a side view of a suture tape construct in accordance withan embodiment;

FIG. 49 shows a side view of a suture tape construct in accordance withan embodiment;

FIG. 50 shows a side view of a suture tape construct in accordance withan embodiment;

FIG. 51 shows a side view of a suture tape construct in accordance withan embodiment;

FIG. 52 shows a side view of a suture tape construct in accordance withan embodiment;

FIG. 53 shows a side view of a suture tape construct in accordance withan embodiment;

FIG. 54 shows a side view of another soft suture anchor in accordancewith an embodiment;

FIG. 55 shows a side view of the soft suture anchor in accordance withthe embodiment of FIG. 54;

FIG. 56 shows a side view of the soft suture anchor in accordance withthe embodiment of FIG. 54;

FIG. 57 shows a side view of the soft suture anchor in accordance withthe embodiment of FIG. 54 with the anchor inserted into bone;

FIG. 58 shows a side view of the soft suture anchor in accordance withthe embodiment of FIG. 57 anchored into bone;

FIG. 59 shows a side view of the soft suture anchor in accordance withthe embodiment of FIG. 54;

FIG. 60 shows a side view of the soft suture anchor in accordance withthe embodiment of FIG. 54;

FIG. 61 shows a side view of the soft suture anchor in accordance withthe embodiment of FIG. 54;

FIG. 62 shows a side view of wavy suture tape in accordance with anembodiment;

FIG. 63 shows a side view of a wavy suture tape construct in accordancewith an embodiment;

FIG. 64 shows a side view of a wavy suture tape construct in accordancewith an embodiment;

FIG. 65 shows a side view of a wavy suture tape construct in accordancewith an embodiment;

FIG. 66 shows a side view of a wavy suture tape construct in accordancewith an embodiment;

FIG. 67 shows a side view of a soft suture anchor in accordance with anembodiment;

FIG. 68 shows a side view of a soft suture anchor in accordance with anembodiment;

FIG. 69 shows a side view of a soft suture anchor in accordance with anembodiment;

FIG. 70 shows a side view of a soft suture anchor in accordance with anembodiment; and

FIG. 71 shows a side view of a soft suture anchor in accordance with anembodiment.

DETAILED DESCRIPTION

References will now be made to embodiments illustrated in the drawingsand specific language which will be used to describe the same. It willnevertheless be understood that no limitation of the scope of theinvention is thereby intended, such alterations and furthermodifications in the illustrated devices, as such further applicationsof the principles of the invention as illustrated therein as beingcontemplated as would normally occur to one skilled in the art to whichthe invention relates.

In accordance with embodiments, a soft suture anchor is provided that ismade entirely of biocompatible suture material, such as, but not limitedto high strength UHMWPE (ultra-high molecular weight polyethylene),polyester, mixtures thereof, and bio-absorbable compounds and mixturesthereof. It is to be understood that any satisfactory material may beused for the soft suture anchor. The use of suture material, as opposedto metal for the anchor, eliminates the possibility of hard loose bodiesin the joint and lowers the risk for damage, among other things. It isalso understood that the soft suture anchor may comprise a mixture ofmaterials, such as a braid comprising UHMWPE and polyester.

In accordance with embodiments, a soft suture anchor is provided thatwhen deployed, an anchor engages a pilot hole. This ensures firm,reliable fixation throughout the healing period.

As compared with metal suture anchors, the soft suture anchors ofembodiments provided herein provide one or more benefits of allowing theuse of a smaller pilot hole diameter and depth which allows multipleanchors to be placed in close proximity, reduces the likelihood ofintersecting anchors when placing multiple anchors, reduces thepossibility of the anchor fracturing the bone, and eliminates use of ananchor that can fracture and cause loose bodies in the joint, amongother benefits.

Embodiments of soft suture tape anchors are described below with thesuture tape comprising a warp and weft weave configuration. It isappreciated and anticipated herein that other suture tape configurationsmay be utilized, such as, but not limited to a braid, and therefore, theembodiments are not limited thereto.

FIGS. 9, 11 and 12 are side views of an embodiment of a soft sutureanchor 1, comprising an anchor 20 with suture ends 11, 12 extendingtherefrom. The suture 10 having a tubular braid structure defining asuture wall 13 having a suture outer surface 14 and a lumen 16therethrough. The suture 10 defines a suture first end 11, a suturesecond end 12 opposite the suture first end 11, and an anchor 20 betweenthe suture first end 11 and the suture second end 12. The anchor 20comprises one or more loops 50 formed by extending one or both of thesuture first end 11 and suture second end 12 through a first penetrationpoint 31 from the suture outer surface 14 into the lumen 16 and througha second penetration point 32 located a predetermined distance from thefirst penetration point 31 from the lumen 16 to the suture outer surface14. The first penetration point 31 and second penetration point 32 arespaced apart and located a predetermined distance from the suture firstend 11 and suture second end 12. The first penetration point 31 and thesecond penetration point 32 define a constrained passageway portion 34therebetween, wherein causing tension between the passageway portion 34and the suture first end 11 and the suture second end 12 causes the oneor more loops 50 to cinch upon the passageway portion 34 operable toengage a pilot hole 72. Skilled persons will readily recognize, furtherin view of FIG. 11, that passageway portion 34, both in the embodimentof FIG. 9, but also the embodiments of FIGS. 16 and 27, is also a “holdregion,” that is, a region that is optimally held in place as ends 11and 12 are pulled to set anchor 20 into surrounding bone.

Referring to FIG. 1, there is shown a length of suture 1 having a suturefirst end 11 and a suture second end 12 opposite the suture first end11. The suture 1 comprises a tubular braid structure defining a suturewall 13 having a suture outer surface 14 and a lumen 16 therethrough. Inthis embodiment, the suture second end 12 is inserted into the lumen 16through an aperture in the suture wall 13 so as to extend for apredetermined distance within the lumen 16, and exits the lumen 16though another aperture in the suture wall 13. Tension placed on thesuture first end 11 and suture second end 12 causes a bunching of thesuture 1 where the suture first end 11 and suture second end 12 extendsfor a predetermined distance within the lumen 16 defining an anchor 20.This bunching presenting a large profile so as to wedge the anchor 20into a pilot hole 72 in bone 70 which is resistant to pull-out. With theanchor 20 coupled into the bone 70, the suture first end 11 and suturesecond end 12 may be used to engage tissue and hold it against the bone70 for healing, such as, but not limited to, tendon reattachment.

An embodiment of a method of making a soft suture anchor 1 comprises:

providing a length of suture 10 having a suture first end 11 and asuture second end 12 opposite the suture first end 11, the suture 10comprising a tubular braid structure defining a suture wall 13 having asuture outer surface 14 and a lumen 16 therethrough, as shown in FIG. 1;

defining a first penetration point 31 and a second penetration point 32a predetermined distance from the first penetration point 31, the firstpenetration point 31 and second penetration point 32 are located apredetermined distance from the suture first end 11 and suture secondend 12, the first penetration point 31 and the second penetration point32 defining a passageway portion 34 therebetween, as shown in FIG. 2;

providing a lacing tool 40 comprising an elongated shaft 43 having ashaft first end 41 and a shaft second end 42, a handle 46 optionallyformed in the shaft second end 42, the shaft first end 41 formed into ahook 45, the shaft first end 41 further comprising a lever 48 pivotallycoupled to the shaft first end 41 adjacent the hook 45 operable to closethe hook 45 in a first position and to open the hook 45 in a secondposition, as shown in FIG. 3;

advancing the hook 45 of the lacing tool 40 from the suture outersurface 14 to the lumen 16 at the first penetration point 31 byadvancing the hook 45 through the strands of the braid without breakingthe strands;

advancing the hook 45 to the second penetration point 32 within thelumen 16;

advancing the hook 45 from the lumen 16 to the suture outer surface 14at the second penetration point 32 by advancing the hook 45 through thestrands of the braid without breaking the strands, a portion of theshaft 43 extending through the lumen 16 between the first penetrationpoint 31 and the second penetration point 32, as shown in FIG. 3;

placing the suture second end 12 into the hook 45 and closing the lever48, as shown in FIG. 4; and

pulling the hook 45 so as to pull the suture second end 12 into thesecond penetration point 32, through the lumen 16 and out of the firstpenetration point 31 forming a loop 50 and removing the lacing tool 40from the suture 10, wherein the loop 50 and passageway portion 34 definean anchor 20, as shown in FIGS. 5 and 6.

An embodiment of a method for using a soft suture anchor 1 comprises:

placing the anchor 20 into a pilot hole 72 drilled into a bone 70, shownin FIG. 11;

engaging a hold-down tool 74 to hold the anchor 20 at about the base 73of the pilot hole 72; and

putting tension on the suture first end 11 and the suture second end 12operable to reduce the size of the loop 50 and to cinch the passagewayportion 34 operable to engage the pilot hole 72, as shown in FIGS. 11and 12.

It is appreciated that the method of forming the loop 50 may be repeatedso as to form multiple loops. Limiting factors for the number of loopsmay be the size of the lumen 16 or the size of the penetration holes atthe first penetration point 31 and the second penetration point 32.

It is appreciated that the size of the anchor 20 may be dependent on thesuture diameter, the number of loops, and the length of the bunchingportion.

A longer passageway portion 34 will create a larger anchor profile ascompared with a smaller passageway portion 34 wherein the distancebetween the first penetration point 31 and second penetration point 32is smaller.

Referring again to FIGS. 1-12, another embodiment is shown comprising alength of suture 10 having a suture first end 11 and a suture second end12 opposite the suture first end 11. The suture 10 comprises a tubularbraid structure defining a suture wall 13 having a suture outer surface14 and a lumen 16 therethrough. In this embodiment, the suture secondend 12 is inserted into the lumen 16 through an aperture in the suturewall 13 so as to extend for a predetermined distance within the lumen16, and exits the lumen 16 though another aperture in the suture wall13, as shown in FIGS. 4-6. The suture first end 11 is inserted into thelumen 16 through an aperture in the suture wall 13 so as to extend for apredetermined distance within the lumen 16 of the suture wall 13, andexits the lumen 16 though another aperture in the suture wall 13, asshown in FIGS. 7-8. Tension placed on the suture first end 11 and suturesecond end 12 causes a bunching of the suture 10 where the suture firstend 11 and suture second end 12 extends for a predetermined distancewithin the lumen 16 defining an anchor 20, this bunching presenting alarge profile so as to wedge the anchor 20 into a pilot hole 72 in bone70 which is resistant to pull-out. With the anchor 20 coupled into thebone 70, the suture first end 11 and suture second end 12 may be used toengage tissue and hold it against the bone 70 for healing, such as, butnot limited to, tendon reattachment.

An embodiment of a method of making a soft suture anchor 1 comprises:

providing a length of suture 10 having a suture first end 11 and asuture second end 12 opposite the suture first end 11, the suture 10comprising a tubular braid structure defining a suture wall 13 having asuture outer surface 14 and a lumen 16 therethrough, as shown in FIG. 1;

defining a first penetration point 31 and a second penetration point 32a predetermined distance from the first penetration point 31, the firstpenetration point 31 and second penetration point 32 are located apredetermined distance from the suture first end 11 and the suturesecond end 12, the first penetration point 31 and the second penetrationpoint 32 defining a passageway portion 34 therebetween, as shown in FIG.2;

providing a lacing tool 40 comprising an elongated shaft 43 having ashaft first end 41 and a shaft second end 42, a handle 46 optionallyformed in the shaft second end 42, the shaft first end 41 defining ahook 45, and a lever 48 pivotally coupled to the shaft first end 41adjacent the hook 45 operable to close the hook 45 in a first positionand to open the hook 45 in a second position;

advancing the hook 45 of the lacing tool 40 from the suture outersurface 14 to the lumen 16 at the first penetration point 31 byadvancing the hook 45 through the strands of the braid without breakingthe strands;

advancing the hook 45 to the second penetration point 32 within thelumen 16;

advancing the hook 45 from the lumen 16 to the suture outer surface 14at the second penetration point 32 by advancing the hook 45 through thestrands of the braid without breaking the strands, a portion of theshaft 43 extending through the lumen 16 between the first penetrationpoint 31 and the second penetration point 32;

placing the suture second end 12 into the hook 45 and closing the lever48;

pulling the hook 45 so as to pull the suture second end 12 into thesecond penetration point 32, through the lumen 16 and out of the firstpenetration point 31 forming a first loop 51 and removing the lacingtool 40 from the suture 10, as shown in FIGS. 4-6;

advancing the hook 45 of the lacing tool 40 from the suture outersurface 14 to the lumen 16 at the second penetration point 32, as shownin FIG. 7;

advancing the hook 45 to the first penetration point 31 within the lumen16;

advancing the hook 45 from the lumen 16 to the suture outer surface 14at the first penetration point 31, a portion of the shaft 43 extendingthrough the lumen 16 between the second penetration point 32 and thefirst penetration point 31;

placing the suture first end 11 into the hook 45 and closing the lever48, as shown in FIG. 7; and

pulling the hook 45 so as to pull the suture first end 11 into the firstpenetration point 31, through the lumen 16 and out of the secondpenetration point 32 forming a second loop 52 and removing the lacingtool 40 from the suture 10, wherein the first loop 51, the second loop52 and the passageway portion 34 define an anchor 20 as shown in FIGS.8-10.

It is appreciated that the method of forming the first loop 51 andsecond loop 52 may be repeated so as to form any number of first loops51 and second loops 52 suitable for a particular purpose. Limitingfactors for the number of first loops 51 and second loops 52 may be thesize of the lumen or the size of the penetration holes at the firstpenetration point and the second penetration point 32.

An embodiment of a method for using a soft suture anchor 1 comprises, asshown in FIGS. 11 and 12:

placing the anchor 20 into a pilot hole 72 drilled into a bone 70, thepilot hole 72 defining a base 73;

engaging a hold-down tool 74 to hold the anchor 20 at about the base 73of the pilot hole 72; and

putting tension on the suture first end 11 and the suture second end 12operable to reduce the size of the loop 50 and to cinch the passagewayportion 34 operable to engage the pilot hole 72.

The hold-down tool 74 is any suitable instrument that is operable tohold the anchor 20 in the pilot hole 72. The hold-down tool 74 maycomprise an elongated member with an end that may be received into thepilot hole 72.

Sliding Suture

FIGS. 13-19 are side views of an embodiment of a soft suture anchor 2including an anchor 20 with suture ends 11, 12 extending therefrom and asliding suture 80 extending through the anchor 20.

The soft suture anchor 2 comprises:

a sliding suture 80 comprising a length of suture having a slidingsuture first end 81 and a sliding suture second end 82 opposite thesliding suture first end 81; and

a suture 10 having a tubular braid structure defining a suture wall 13having a suture outer surface 14 and a lumen 16 therethrough, the suture10 defining a suture first end 11, a suture second end 12 opposite thesuture first end 11, and an anchor 20 between the suture first end 11and the suture second end 12, the anchor 20 comprising one or more loopsformed by extending one or both of the suture first end 11 and suturesecond end 12 through a first penetration point 31 from the suture outersurface 14 into the lumen 16 and through a second penetration point 32located a predetermined distance from the first penetration point 31from the lumen 16 to the suture outer surface 14, the first penetrationpoint 31 and second penetration point 32 being spaced apart and locateda predetermined distance from the suture first end 11 and suture secondend 12, the first penetration point 31 and the second penetration point32 defining a passageway portion 34 therebetween, wherein causingtension between the anchor 20 and the suture first end 11 and the suturesecond end 12 causes the one or more loops to cinch upon the passagewayportion 34 operable to engage a pilot hole, wherein the sliding suture80 extends through the lumen 16 extending from the first penetrationpoint 31 and second penetration point 32, the sliding suture 80 mayslide through the anchor 20 along the length of the sliding suture 80.

Referring to FIGS. 1-6 and 13-19 are side views of an embodiment of asoft suture anchor 2, a length of suture 1 having a suture first end 11and a suture second end 12 opposite the suture first end 11. The suture1 comprises a tubular braid structure defining a suture wall 13 having asuture outer surface 14 and a lumen 16 therethrough, as shown in FIGS.1-2. In this embodiment, the suture second end 12 is inserted into thelumen 16 through an aperture in the suture wall 13 so as to extend for apredetermined distance within the lumen 16 and exits the lumen 16 thoughanother aperture in the suture wall 13, as shown in FIGS. 3-6. A slidingsuture 80 comprising a length of a second suture, is inserted into thelumen 16 through the aperture in the wall of the tubular braid so as toextend for a predetermined distance within the lumen of the tubularbraid and exits the lumen though another aperture in the wall of thetubular braid, as shown in FIGS. 13-15. Tension placed on the suturefirst end 11 and suture second end 12 causes a bunching of the suture 1where the suture first end 11 and suture second end 12 extends for apredetermined distance within the lumen 16 defining an anchor 20, thisbunching presenting a large profile so as to wedge the anchor 20 into apilot hole 72 in bone 70 which is resistant to pull-out, as shown inFIGS. 18-19. The sliding suture 80 is operable to slide within theanchor 20 along the length of the sliding suture 80. With the anchor 20coupled into the bone 70, the suture second end 12 and suture second end12 may be used to engage tissue and hold it against the bone 70 forhealing, such as, but not limited to, tendon reattachment.

Referring to FIGS. 1-6 and 13-19, an embodiment of a method of making asoft suture anchor 2 comprises:

providing a length of suture 10 having a suture first end 11 and asuture second end 12 opposite the suture first end 11, the suture 10comprising a tubular braid structure defining a suture wall 13 having asuture outer surface 14 and a lumen 16 therethrough, as shown in FIGS.1-2;

defining a first penetration point 31 and a second penetration point 32a predetermined distance from the first penetration point 31, the firstpenetration point 31 and second penetration point 32 are located apredetermined distance from the suture first end 11 and suture secondend 12, the first penetration point 31 and the second penetration point32 defining a passageway portion 34 therebetween, as shown in FIG. 3;

providing a lacing tool 40 comprising an elongated shaft 43 having ashaft first end 41 and a shaft second end 42, a handle 46 optionallyformed in the shaft second end 42, the shaft first end 41 formed into ahook 45, the shaft first end 41 further comprising a lever 48 pivotallycoupled to the shaft first end 41 adjacent the hook 45 operable to closethe hook 45 in a first position and to open the hook 45 in a secondposition, as shown in FIG. 4;

advancing the hook 45 of the lacing tool 40 from the suture outersurface 14 to the lumen 16 at the first penetration point 31 byadvancing the hook 45 through the strands of the braid without breakingthe strands;

advancing the hook 45 to the second penetration point 32 within thelumen 16;

advancing the hook 45 from the lumen 16 to the suture outer surface 14at the second penetration point 32 by advancing the hook 45 through thestrands of the braid without breaking the strands, a portion of theshaft 43 extending through the lumen 16 between the first penetrationpoint 31 and the second penetration point 32;

placing the suture second end 12 into the hook 45 and closing the lever48, as shown in FIG. 4;

pulling the hook 45 so as to pull the suture second end 12 into thesecond penetration point 32, through the lumen 16 and out of the firstpenetration point 31 forming a loop 50 and removing the lacing tool 40from the suture 10, wherein the loop and passageway portion 34 define ananchor 20, as shown in FIGS. 5-6;

providing a length of sliding suture 80 having a sliding suture firstend 81 and a sliding suture second end 82 opposite the sliding suturefirst end 81, as shown in FIG. 13;

placing the sliding suture first end 81 into the hook 45 and closing thelever 48, as shown in FIG. 13; and

pulling the hook 45 so as to pull the sliding suture first end 81 intothe first penetration point 31, through the lumen 16 and out of thesecond penetration point 32, removing the lacing tool 40 from the suture10, wherein the sliding suture 80 may slide relative to the anchor 20along the length of the sliding suture 80, as shown in FIG. 14.

Referring to FIGS. 18-19, an embodiment of a method for using a softsuture anchor 2 comprises:

placing the anchor 20 into a pilot hole 72 drilled into a bone 70defining a base 73;

engaging a hold-down tool 74 to hold the anchor 20 at about the base 73of the pilot hole 72, as shown in FIGS. 18-19; and

putting tension on the suture first end 11 and the suture second end 12operable to reduce the size of the loop 50 and to cinch the passagewayportion 34 such that the anchor 20 engages the pilot hole 72, whereinthe sliding suture 80 may slide through the anchor 20 along the lengthof the sliding suture 80, as shown in FIG. 19.

It is appreciated that the method of forming the loop 50 may be repeatedso as to form multiple loops. Limiting factors for the number of loopsmay be the size of the lumen 16 or the size of the penetration holes atthe first penetration point 31 and the second penetration point 32.

It is appreciated that the size of the anchor 20 may be dependent on thesuture diameter, the number of loops, and the length of the bunchingportion.

A longer passageway portion 34 will create a larger anchor 20 profile ascompared with a smaller passageway portion 34 wherein the distancebetween the first penetration point 31 and second penetration point 32is smaller.

The sliding suture 80 may be a monofilament or multi-filament twisted orbraided suture suitable for a particular purpose. The slidingcharacteristics of the sliding suture 80 along the length of the slidingsuture 80 may be dependent on the surface roughness, compressibility andlubricity, such as from a lubricant, of the sliding suture 80, as wellas the tightness of the anchor 20 against the sliding suture 80.

In accordance with another embodiment, referring to FIGS. 1-6 and 13-19,there is shown a length of suture 10 having a suture first end 11 and asuture second end 12 opposite the suture first end 11. The suture 10comprises a tubular braid structure defining a suture wall 13 having asuture outer surface 14 and a lumen 16 therethrough. In this embodiment,the suture second end 12 is inserted into the lumen 16 through anaperture in the suture wall 13 so as to extend for a predetermineddistance within the lumen 16 and exits the lumen 16 though anotheraperture in the suture wall 13, as shown in FIGS. 3-6. The suture firstend 11 is inserted into the lumen 16 through an aperture in the suturewall 13 so as to extend for a predetermined distance within the lumen 16of the suture 10 and exits the lumen 16 though another aperture in thesuture wall 13, as shown in FIGS. 14-15. A sliding suture 80 is insertedinto the lumen 16 through the aperture in the suture wall 13 so as toextend for a predetermined distance within the lumen 16 and exits thelumen 16 though another aperture in the suture wall 13, as shown inFIGS. 13-15. Tension placed on the suture first end 11 and suture secondend 12 causes a bunching of the suture 10 where the suture first end 11and suture second end 12 extends for a predetermined distance within thelumen 16 defining an anchor 20, this bunching presenting a profile so asto wedge the anchor 20 into a pilot hole 72 in bone 70 which isresistant to pull-out, as shown in FIGS. 18-19. The sliding suture 80 isoperable to slide within the anchor 20 along the length of the slidingsuture 80. With the anchor 20 coupled into the bone 70, the suture firstend 11 and suture second end 12 may be used to engage tissue and hold itagainst the bone 70 for healing, such as, but not limited to, tendonreattachment.

Referring to FIGS. 1-6 and 13-19, an embodiment of a method of making asoft suture anchor 2 comprises:

providing a length of suture 10 having a suture first end 11 and asuture second end 12 opposite the suture first end 11, the suture 10comprising a tubular braid structure defining a suture wall 13 having asuture outer surface 14 and a lumen 16 therethrough, as shown in FIG. 1;

defining a first penetration point 31 and a second penetration point 32a predetermined distance from the first penetration point 31, the firstpenetration point 31 and second penetration point 32 are located apredetermined distance from the suture first end 11 and the suturesecond end 12, the first penetration point 31 and the second penetrationpoint 32 defining a passageway portion 34 therebetween, as shown in FIG.2;

providing a lacing tool 40 comprising an elongated shaft 43 having ashaft first end 41 and a shaft second end 42, a handle 46 optionallyformed in the shaft second end 42, the shaft first end 41 defining ahook 45, and a lever 48 pivotally coupled to the shaft first end 41adjacent the hook 45 operable to close the hook 45 in a first positionand to open the hook 45 in a second position, as shown in FIG. 3;

advancing the hook 45 of the lacing tool 40 from the suture outersurface 14 to the lumen 16 at the first penetration point 31 byadvancing the hook 45 through the strands of the braid without breakingthe strands;

advancing the hook 45 to the second penetration point 32 within thelumen 16;

advancing the hook 45 from the lumen 16 to the suture outer surface 14at the second penetration point 32 by advancing the hook 45 through thestrands of the braid without breaking the strands, a portion of theshaft 43 extending through the lumen 16 between the first penetrationpoint 31 and the second penetration point 32, as shown in FIG. 3;

placing the suture second end 12 into the hook 45 and closing the lever48, as shown in FIG. 4;

pulling the hook 45 so as to pull the suture second end 12 into thesecond penetration point 32, through the lumen 16 and out of the firstpenetration point 31 forming a first loop 51 and removing the lacingtool 40 from the suture 10, as shown in FIGS. 5-6;

advancing the hook 45 of the lacing tool 40 from the suture outersurface 14 to the lumen 16 at the second penetration point 32;

advancing the hook 45 to the first penetration point 31 within the lumen16;

advancing the hook 45 from the lumen 16 to the suture outer surface 14at the first penetration point 31, a portion of the shaft 43 extendingthrough the lumen 16 between the second penetration point 32 and thefirst penetration point 31, as shown in FIG. 13;

providing a length of sliding suture 80 having a sliding suture firstend 81 and a sliding suture second end 82 opposite the sliding suturefirst end 81, as shown in FIG. 13;

placing the sliding suture first end 81 into the hook 45 and closing thelever 48, as shown in FIG. 14;

pulling the hook 45 so as to pull the sliding suture first end 81 intothe first penetration point 31, through the lumen 16 and out of thesecond penetration point 32 removing the lacing tool 40 from the suture10, as shown in FIG. 14;

advancing the hook 45 of the lacing tool 40 from the suture outersurface 14 to the lumen 16 at the second penetration point 32;

advancing the hook 45 to the first penetration point 31 within the lumen16;

advancing the hook 45 from the lumen 16 to the suture outer surface 14at the first penetration point 31, a portion of the shaft 43 extendingthrough the lumen 16 between the second penetration point 32 and thefirst penetration point 31;

placing the suture first end 11 into the hook 45 and closing the lever48, as shown in FIG. 14; and

pulling the hook 45 so as to pull the suture first end 11 into the firstpenetration point 31, through the lumen 16 and out of the secondpenetration point 32 forming a second loop 52 and removing the lacingtool 40 from the suture 10, wherein the first loop 51, the second loop52 and the passageway portion 34 define an anchor 20, wherein thesliding suture 80 may slide relative to the anchor 20 along the lengthof the sliding suture 80, as shown in FIGS. 15-17.

It is appreciated that the method of forming the first loop 51 andsecond loop 52 may be repeated so as to form any number of first loops51 and second loops 52 suitable for a particular purpose. Limitingfactors for the number of first loops 51 and second loops 52 may be thesize of the lumen or the size of the penetration holes at the firstpenetration point and the second penetration point 32.

Referring to FIGS. 18-19, an embodiment of a method for using a softsuture anchor 2 comprises:

placing the anchor 20 into a pilot hole 72 drilled into a bone 70, thepilot hole 72 defining a base 73, as shown in FIG. 18;

engaging a hold-down tool 74 to hold the anchor 20 at about the base 73of the pilot hole 72, as shown in FIG. 18; and

putting tension on the suture first end 11 and the suture second end 12operable to reduce the size of the loop 50 and to cinch the passagewayportion 34 such that the anchor 20 engages the pilot hole 72, whereinthe sliding suture 80 may slide through the anchor 20 along the lengthof the sliding suture 80, as shown in FIG. 19.

The hold-down tool 74 is any suitable instrument that is operable tohold the anchor 20 in the pilot hole 72. The hold-down tool 74 maycomprise an elongated member with an end that may be received into thepilot hole 72.

It is appreciated that the method of forming the first loop 51 andsecond loop 52 may be repeated so as to form any number of first loops51 and second loops 52 suitable for a particular purpose. Limitingfactors for the number of first loops 51 and second loops 52 may be thesize of the lumen or the size of the penetration holes at the firstpenetration point 31 and the second penetration point 32.

The sliding suture 80 may be a monofilament or multi-filament twisted orbraided suture suitable for a particular purpose. The slidingcharacteristics of the sliding suture relative to the anchor 20 may bedependent on the surface roughness, compressibility and lubricity, suchas from a lubricant, of the sliding suture 80, as well as the tightnessof the anchor 20 against the sliding suture 80.

Bulking Suture

The size of the anchor 20 may be further increased by the inclusion of abulking suture 90, that is, an additional length of suture that issubstantially the same or smaller in length as the passageway portion 34between the first penetration point 31 and a second penetration point32. The bulking suture 90 includes a bulking suture first end 91 and abulking suture second end 92 opposite the bulking suture first end 91.The bulking suture 90 comprises a tubular structure defining a bulkingsuture lumen 93 therethrough.

FIGS. 30-33 are side views of an embodiment of a soft suture anchor 3including an anchor 20 with bulking suture 90, and suture ends 11, 12extending from the anchor 20.

Referring to FIGS. 20-33, an embodiment of a method of making a softsuture anchor 3, comprising:

a bulking suture 90 comprising a length of suture having a bulkingsuture first end 91 and a bulking suture second end 92 opposite thebulking suture first end 91, the bulking suture 90 comprising a tubularstructure defining a bulking suture lumen 93 therethrough, as shown inFIG. 21; and

a suture 10 having a tubular braid structure defining a suture wall 13having a suture outer surface 14 and a lumen 16 therethrough, the suture10 defining a suture first end 11, a suture second end 12 opposite thesuture first end 11, and an anchor 20 between the suture first end 11and the suture second end 12, the anchor 20 comprising one or more loopsformed by extending one or both of the suture first end 11 and suturesecond end 12 through a first penetration point 31 from the suture outersurface 14 into the lumen 16 and through a second penetration point 32located a predetermined distance from the first penetration point 31from the lumen 16 to the suture outer surface 14, the first penetrationpoint 31 and second penetration point 32 being spaced apart and locateda predetermined distance from the suture first end 11 and suture secondend 12, the first penetration point 31 and the second penetration point32 defining a passageway portion 34 therebetween, as shown in FIGS.20-27,

wherein the bulking suture 90 has a length that is substantially thesame or smaller as the passageway portion 34, wherein the passagewayportion 34 extends within the bulking suture lumen, as shown in FIG. 23,

wherein causing tension between the anchor 20 and the suture first end11 and the suture second end 12 causes the one or more loops 50 to cinchupon the passageway portion 34 and the bulking suture 90 operable toengage a pilot hole 72, as shown in FIGS. 30-33.

Referring to FIGS. 20-33, there is shown a length of suture 10 having asuture first end 11 and a suture second end 12 opposite the suture firstend 11. The suture 10 comprises a tubular braid structure defining asuture wall 13 having a suture outer surface 14 and a lumen 16therethrough, as shown in FIG. 20. In this embodiment, a second suture,called a bulking suture 90, is placed over a portion of the suture 10,as shown in FIGS. 21-22. The suture second end 12 is inserted into thelumen 16 through an aperture in the suture wall 13 adjacent a bulkingsuture first end 91 of the bulking suture 90 so as to extend for apredetermined distance within the lumen 16 and exits the lumen 16 thoughanother aperture in the suture wall 13 adjacent a bulking suture secondend 92 of the bulking suture 90, as shown in FIGS. 23-27. Tension placedon the suture first end 11 and suture second end 12 causes a bunching ofthe suture 10 where the suture first end 11 and suture second end 12extends for a predetermined distance within the lumen 16 and about thebulking suture 90 defining an anchor 20, this bunching presenting alarge profile so as to wedge the anchor 20 into a pilot hole 72 in bone70 which is resistant to pull-out, as shown in FIGS. 30-33. With theanchor 20 coupled into the bone 70, the suture first end 11 and suturesecond end 12 may be used to engage tissue and hold it against the bone70 for healing, such as, but not limited to, tendon reattachment.

Referring to FIGS. 20-33, an embodiment of a method of making a softsuture anchor 3 comprises:

providing a length of suture 10 having a suture first end 11 and asuture second end 12 opposite the suture first end 11, the suture 10comprising a tubular braid structure defining a suture wall 13 having asuture outer surface 14 and a lumen 16 therethrough, as shown in FIG.20;

defining a first penetration point 31 and a second penetration point 32a predetermined distance from the first penetration point 31, the firstpenetration point 31 and second penetration point 32 are located apredetermined distance from the suture first end 11 and suture secondend 12, the first penetration point 31 and the second penetration point32 defining a passageway portion 34 therebetween, as shown in FIG. 23;

providing a lacing tool 40 comprising an elongated shaft 43 having ashaft first end 41 and a shaft second end 42, a handle 46 optionallyformed in the shaft second end 42, the shaft first end 41 formed into ahook 45, the shaft first end 41 further comprising a lever 48 pivotallycoupled to the shaft first end 41 adjacent the hook 45 operable to closethe hook 45 in a first position and to open the hook 45 in a secondposition, as shown in FIG. 21;

providing a length of bulking suture 90 that is substantially the sameor smaller in length as the passageway portion 34 between the firstpenetration point 31 and a second penetration point 32, the bulkingsuture 90 including a bulking suture first end 91 and a bulking suturesecond end 92 opposite the bulking suture first end 91, the bulkingsuture 90 comprising a tubular structure defining a bulking suture lumentherethrough, as shown in FIG. 21;

threading the suture second end 12 through the bulking suture lumen 93and advancing the bulking suture 90 to the passageway portion 34, asshown in FIG. 22;

in another embodiment, threading comprises: advancing the hook 45 of thelacing tool 40 through the bulking suture lumen 94 such that the bulkingsuture is disposed on the shaft of the lacing tool 40 between the hook45 and the handle; placing the suture second end 12 into the hook 45 andclosing the lever 48; and pulling the hook 45 so as to pull the suturesecond end 12 into and through the bulking suture lumen and removing thelacing tool 40 from the bulking suture lumen, as shown in FIG. 21;

advancing the hook 45 of the lacing tool 40 from the suture outersurface 14 to the lumen 16 at the first penetration point 31 byadvancing the hook 45 through the strands of the braid without breakingthe strands;

advancing the hook 45 to the second penetration point 32 within thelumen 16;

advancing the hook 45 from the lumen 16 to the suture outer surface 14at the second penetration point 32 by advancing the hook 45 through thestrands of the braid without breaking the strands, a portion of theshaft 43 extending through the lumen 16 between the first penetrationpoint 31 and the second penetration point 32, as shown in FIG. 24;

placing the suture second end 12 into the hook 45 and closing the lever48, as shown in FIG. 25;

pulling the hook 45 so as to pull the suture second end 12 into thesecond penetration point 32, through the lumen 16 and out of the firstpenetration point 31 forming a loop 50 and removing the lacing tool 40from the suture 10, wherein the loop 50, the bulking suture 90 and thepassageway portion 34 define an anchor 20, as shown in FIGS. 26-27.

Referring to FIGS. 32-33, an embodiment of a method for using a softsuture anchor 3 comprises:

placing the anchor 20 into a pilot hole 72 drilled into a bone 70, asshown in FIG. 32;

engaging a hold-down tool 74 to hold the anchor 20 at about the base 73of the pilot hole 72, as shown in FIG. 32; and

putting tension on the suture first end 11 and the suture second end 12operable to reduce the size of the loop 50 and to cinch the passagewayportion 34 and bulking suture 90 such that the anchor 20 engages thepilot hole 72, as shown in FIG. 33.

The hold-down tool 74 is any suitable instrument that is operable tohold the anchor 20 in the pilot hole 72. The hold-down tool 74 maycomprise an elongated member with an end that may be received into thepilot hole 72.

It is appreciated that the method of forming the loop 50 may be repeatedso as to form multiple loops. Limiting factors for the number of loopsmay be the size of the lumen 16 or the size of the penetration holes atthe first penetration point 31 and the second penetration point 32.

It is appreciated that the size of the anchor 20 may be dependent on thesuture diameter, the number of loops, and the length of the bunchingportion, and the length, size and thickness of the bulking suture 90,among other things.

A longer passageway portion 34 will create a larger anchor profile ascompared with a smaller passageway portion 34 wherein the distancebetween the first penetration point 31 and second penetration point 32is smaller.

A longer or thicker bulking suture 90 will create a larger anchorprofile as compared with a shorter or thinner bulking suture 90.

Referring to FIGS. 20-33, there is shown a length of suture 10 having asuture first end 11 and a suture second end 12 opposite the suture firstend 11. The suture 10 comprises a tubular braid structure defining asuture wall 13 having a suture outer surface 14 and a lumen 16therethrough, as shown in FIG. 20.

In this embodiment, a second suture, called a bulking suture 90, isplaced over a portion of the suture 10, as shown in FIG. 22. the suturesecond end 12 is inserted into the lumen 16 through an aperture in thesuture wall 13 adjacent a bulking suture first end 91 of the bulkingsuture 90 so as to extend for a predetermined distance within the lumen16 and exits the lumen 16 though another aperture in the suture wall 13adjacent a bulking suture second end 92 of the bulking suture 90, asshown in FIG. 27. The suture first end 11 is inserted into the lumen 16through an aperture in the suture wall 13 so as to extend for apredetermined distance within the lumen 16 of the suture wall 13 andexits the lumen 16 though another aperture in the suture wall 13, asshown in FIGS. 28-29. Tension placed on the suture first end 11 andsuture second end 12 causes a bunching of the suture 10 where the suturefirst end 11 and suture second end 12 extends for a predetermineddistance within the lumen 16 and about the bulking suture defining ananchor 20, this bunching presenting a large profile so as to wedge theanchor 20 into a pilot hole 72 in bone 70 which is resistant topull-out, as shown in FIGS. 32-33. With the anchor 20 coupled into thebone 70, the suture first end 11 and suture second end 12 may be used toengage tissue and hold it against the bone 70 for healing, such as, butnot limited to, tendon reattachment.

Referring to FIGS. 20-33, an embodiment of a method of making a softsuture anchor 3 comprises:

providing a length of suture 10 having a suture first end 11 and asuture second end 12 opposite the suture first end 11, the suture 10comprising a tubular braid structure defining a suture wall 13 having asuture outer surface 14 and a lumen 16 therethrough, as shown in FIG.20;

defining a first penetration point 31 and a second penetration point 32a predetermined distance from the first penetration point 31 on thesuture 10, the first penetration point 31 and second penetration point32 are located a predetermined distance from the suture first end 11 andsuture second end 12, the first penetration point 31 and the secondpenetration point 32 defining a passageway portion 34 therebetween, asshown in FIGS. 23-24;

providing a lacing tool 40 comprising an elongated shaft 43 having ashaft first end 41 and a shaft second end 42, a handle 46 optionallyformed in the shaft second end 42, the shaft first end 41 formed into ahook 45, the shaft first end 41 further comprising a lever 48 pivotallycoupled to the shaft first end 41 adjacent the hook 45 operable to closethe hook 45 in a first position and to open the hook 45 in a secondposition, as shown in FIG. 24;

providing a length of bulking suture 90 that is substantially the sameor smaller in length as the passageway portion 34 between the firstpenetration point 31 and a second penetration point 32, the bulkingsuture 90 including a bulking suture first end 91 and a bulking suturesecond end 92 opposite the bulking suture first end 91, the bulkingsuture 90 comprising a tubular structure defining a bulking suture lumen93 therethrough, as shown in FIGS. 22-23;

threading the suture second end 12 through the bulking suture lumen 93and advancing the bulking suture 90 to the passageway portion 34, asshown in FIG. 22;

in another embodiment, threading comprises: advancing the hook 45 of thelacing tool 40 through the bulking suture lumen 93 such that the bulkingsuture 90 is disposed on the shaft of the lacing tool 40 between thehook 45 and the handle; placing the suture second end 12 into the hook45 and closing the lever 48; and pulling the hook 45 so as to pull thesuture second end 12 into and through the bulking suture lumen andremoving the lacing tool 40 from the bulking suture lumen, as shown inFIGS. 21-22;

advancing the hook 45 of the lacing tool 40 from the suture outersurface 14 to the lumen 16 at the first penetration point 31 byadvancing the hook 45 through the strands of the braid without breakingthe strands;

advancing the hook 45 to the second penetration point 32 within thelumen 16;

advancing the hook 45 from the lumen 16 to the suture outer surface 14at the second penetration point 32 by advancing the hook 45 through thestrands of the braid without breaking the strands, a portion of theshaft 43 extending through the lumen 16 between the first penetrationpoint 31 and the second penetration point 32, as shown in FIG. 24;

placing the suture second end 12 into the hook 45 and closing the lever48, as shown in FIG. 25;

pulling the hook 45 so as to pull the suture second end 12 into thesecond penetration point 32, through the lumen 16 and out of the firstpenetration point 31 forming a loop 50 and removing the lacing tool 40from the suture 10, as shown in FIGS. 26-27;

advancing the hook 45 of the lacing tool 40 from the suture outersurface 14 to the lumen 16 at the second penetration point 32;

advancing the hook 45 to the first penetration point 31 within the lumen16;

advancing the hook 45 from the lumen 16 to the suture outer surface 14at the first penetration point 31, a portion of the shaft 43 extendingthrough the lumen 16 between the second penetration point 32 and thefirst penetration point 31;

placing the suture first end 11 into the hook 45 and closing the lever48, as shown in FIG. 28; and

pulling the hook 45 so as to pull the suture first end 11 into the firstpenetration point 31, through the lumen 16 and out of the secondpenetration point 32 forming a second loop 52 and removing the lacingtool 40 from the suture 10, wherein the first loop 51, the second loop52, the passageway portion 34, and the bulking suture 90 define ananchor 20, as shown in FIG. 29-31.

Referring to FIGS. 32-33, an embodiment of a method for using a softsuture anchor 3 comprises:

placing the anchor 20 into a pilot hole 72 drilled into a bone 70, asshown in FIG. 32;

engaging a hold-down tool 74 to hold the anchor 20 at about the base 73of the pilot hole 72, as shown in FIG. 32; and

putting tension on the suture first end 11 and the suture second end 12operable to reduce the size of the loop 50 and the second loop 52 tocinch the passageway portion 34 and bulking suture 90 operable to engagethe pilot hole 72, as shown in FIG. 33.

The hold-down tool 74 is any suitable instrument that is operable tohold the anchor 20 in the pilot hole 72. The hold-down tool 74 maycomprise an elongated member with an end that may be received into thepilot hole 72.

It is appreciated that the method of forming the first loop 51 and thesecond loop 52 may be repeated so as to form multiple loops. Limitingfactors for the number of loops may be the size of the lumen 16 or thesize of the penetration holes at the first penetration point 31 and thesecond penetration point 32.

It is appreciated that the size of the anchor may be dependent on thesuture diameter, the number of loops, and the length of the bunchingportion, and the length, size and thickness of the bulking suture 90,among other things.

A longer passageway portion 34 will create a larger anchor profile ascompared with a smaller passageway portion 34 wherein the distancebetween the first penetration point 31 and second penetration point 32is smaller.

A longer or thicker bulking suture 90 will create a larger anchorprofile as compared with a shorter or thinner bulking suture 90.

FIGS. 37-40 are side views of an embodiment of a soft suture anchor 4including an anchor 20 with a bulking suture 90, with suture ends 11, 12extending from the anchor 20, and a sliding suture 80 extending throughthe anchor 20.

Referring to FIGS. 20-27 and 34-40, a soft suture anchor 4, comprising,

a sliding suture 80 comprising a length of suture having a slidingsuture first end 81 and a sliding suture second end 82 opposite thesliding suture first end 81;

a bulking suture 90 comprising a length of suture having a bulkingsuture first end 91 and a bulking suture second end 92 opposite thebulking suture first end 91, the bulking suture 90 comprising a tubularstructure defining a bulking suture lumen 93 therethrough; and

a suture 10 having a tubular braid structure defining a suture wall 13having a suture outer surface 14 and a lumen 16 therethrough, the suture10 defining a suture first end 11, a suture second end 12 opposite thesuture first end 11, and an anchor 20 between the suture first end 11and the suture second end 12, the anchor 20 comprising one or more loopsformed by extending one or both of the suture first end 11 and suturesecond end 12 through a first penetration point 31 from the suture outersurface 14 into the lumen 16 and through a second penetration point 32located a predetermined distance from the first penetration point 31from the lumen 16 to the suture outer surface 14, the first penetrationpoint 31 and second penetration point 32 being spaced apart and locateda predetermined distance from the suture first end 11 and suture secondend 12, the first penetration point 31 and the second penetration point32 defining a passageway portion 34 therebetween,

wherein the bulking suture has a length that is substantially the sameor smaller as the passageway portion 34, wherein the passageway portion34 extends within the bulking suture lumen 93, wherein the passagewayportion 34, the one or more loops, and the bulking suture 90 define ananchor 20,

wherein the sliding suture 80 extends through the lumen 16 extendingfrom the first penetration point 31 and second penetration point 32,

wherein causing tension between the anchor 20 and the suture first end11 and the suture second end 12 causes the one or more loops to cinchupon the passageway portion 34 and the bulking suture 90 operable toengage a pilot hole 72, wherein the sliding suture 80 may slide throughthe anchor 20 along the length of the sliding suture 80.

Referring to FIGS. 20-27 and 34-40, there is shown a length of suture 4having a suture first end 11 and a suture second end 12 opposite thesuture first end 11. The suture 10 comprises a tubular braid structuredefining a suture wall 13 having a suture outer surface 14 and a lumen16 therethrough, as shown in FIG. 20.

A bulking suture 90 is placed over a portion of the suture 10, as shownin FIG. 22. The suture second end 12 is inserted into the lumen 16through an aperture in the suture wall 13 adjacent a bulking suturefirst end 91 of the bulking suture 90 so as to extend for apredetermined distance within the lumen 16, and exits the lumen 16though another aperture in the suture wall 13 adjacent a bulking suturesecond end 92 of the bulking suture 90, as shown in FIGS. 24-27. Asliding suture 80 comprising a length of a second suture, is insertedinto the lumen 16 through the aperture in the suture wall 13 of thesuture 10 so as to extend for a predetermined distance within the lumen16 of the suture 10 and exits the lumen 16 though another aperture inthe suture wall 13 of the suture 10, as shown in FIGS. 34-36. Tensionplaced on the suture first end 11 and suture second end 12 causes abunching of the suture 4 where the suture first end 11 and suture secondend 12 extends for a predetermined distance within the lumen 16 andabout the bulking suture defining an anchor 20, this bunching presentinga large profile so as to wedge the anchor 20 into a pilot hole 72 inbone 70 which is resistant to pull-out. The sliding suture 80 isoperable to slide within the anchor 20 along the length of the slidingsuture 80. With the anchor 20 coupled into the bone 70, the suture firstend 11 and suture second end 12 may be used to engage tissue and hold itagainst the bone 70 for healing, such as, but not limited to, tendonreattachment, as shown in FIGS. 37-40.

Referring to FIGS. 20-27 and 34-40, an embodiment of a method of makinga soft suture anchor 4 comprises:

providing a length of suture 10 having a suture first end 11 and asuture second end 12 opposite the suture first end 11, the suture 10comprising a tubular braid structure defining a suture wall 13 having asuture outer surface 14 and a lumen 16 therethrough, as shown in FIG.20;

defining a first penetration point 31 and a second penetration point 32a predetermined distance from the first penetration point 31, the firstpenetration point 31 and second penetration point 32 are located apredetermined distance from the suture first end 11 and suture secondend 12, the first penetration point 31 and the second penetration point32 defining a passageway portion 34 therebetween, as shown in FIG. 34;

providing a lacing tool 40 comprising an elongated shaft 43 having ashaft first end 41 and a shaft second end 42, a handle 46 optionallyformed in the shaft second end 42, the shaft first end 41 formed into ahook 45, the shaft first end 41 further comprising a lever 48 pivotallycoupled to the shaft first end 41 adjacent the hook 45 operable to closethe hook 45 in a first position and to open the hook 45 in a secondposition, as shown in FIG. 21;

providing a length of bulking suture that is substantially the same orsmaller in length as the passageway portion 34 between the firstpenetration point and a second penetration point 32, the bulking sutureincluding a bulking suture first end 91 and a bulking suture second end92 opposite the bulking suture first end 91, the bulking suturecomprising a tubular structure defining a bulking suture lumentherethrough, as shown in FIG. 21;

threading the suture second end 12 through the bulking suture lumen andadvancing the bulking suture to the passageway portion 34, as shown inFIG. 22;

in another embodiment, threading comprises: advancing the hook 45 of thelacing tool 40 through the bulking suture lumen such that the bulkingsuture is disposed on the shaft of the lacing tool 40 between the hook45 and the handle; placing the suture second end 12 into the hook 45 andclosing the lever 48; and pulling the hook 45 so as to pull the suturesecond end 12 into and through the bulking suture lumen and removing thelacing tool 40 from the bulking suture lumen, as shown in FIG. 21;

advancing the hook 45 of the lacing tool 40 from the suture outersurface 14 to the lumen 16 at the first penetration point 31 byadvancing the hook 45 through the strands of the braid without breakingthe strands;

advancing the hook 45 to the second penetration point 32 within thelumen 16;

advancing the hook 45 from the lumen 16 to the suture outer surface 14at the second penetration point 32 by advancing the hook 45 through thestrands of the braid without breaking the strands, a portion of theshaft 43 extending through the lumen 16 between the first penetrationpoint 31 and the second penetration point 32, as shown in FIG. 24;

placing the suture second end 12 into the hook 45 and closing the lever48, as shown in FIG. 25;

pulling the hook 45 so as to pull the suture second end 12 into thesecond penetration point 32, through the lumen 16 and out of the firstpenetration point 31 forming a loop 50 and removing the lacing tool 40from the suture 10, wherein the loop 50, the bulking suture 90, and thepassageway portion 34 define an anchor 20, as shown in FIG. 26-27;

providing a length of sliding suture 80 having a sliding suture firstend 81 and a sliding suture second end 82 opposite the sliding suturefirst end 81, as shown in FIG. 34;

placing the sliding suture first end 81 into the hook 45 and closing thelever 48, as shown in FIG. 34; and

pulling the hook 45 so as to pull the sliding suture first end 81 intothe first penetration point 31, through the lumen 16 and out of thesecond penetration point 32, removing the lacing tool 40 from the suture10, wherein the sliding suture 80 may slide relative to the anchor 20along the length of the sliding suture 80, as shown in FIG. 35.

Referring to FIGS. 39-40, an embodiment of a method for using a softsuture anchor 4 comprises:

placing the anchor 20 into a pilot hole 72 drilled into a bone 70defining a base 73, as shown in FIG. 39;

engaging a hold-down tool 74 to hold the anchor 20 at about the base 73of the pilot hole 72, as shown in FIG. 39; and

putting tension on the suture first end 11 and the suture second end 12operable to reduce the size of the loop 50 and to cinch the bulkingsuture 90 and the passageway portion 34 operable to engage the pilothole 72, wherein the sliding suture may slide through the anchor 20along the length of the sliding suture 80, as shown in FIG. 40.

The hold-down tool 74 is any suitable instrument that is operable tohold the anchor 20 in the pilot hole 72. The hold-down tool 74 maycomprise an elongated member with an end that may be received into thepilot hole 72.

It is appreciated that the method of forming the loop 50 may be repeatedso as to form multiple loops. Limiting factors for the number of loopsmay be the size of the lumen 16 or the size of the penetration holes atthe first penetration point 31 and the second penetration point 32.

It is appreciated that the size of the anchor may be dependent on thesuture diameter, the number of loops, and the length of the bunchingportion.

A longer passageway portion 34 will create a larger anchor profile ascompared with a smaller passageway portion 34 wherein the distancebetween the first penetration point 31 and second penetration point 32is smaller.

The sliding suture 80 may be a monofilament or multi-filament twisted orbraided suture suitable for a particular purpose. The slidingcharacteristics of the sliding suture 80 along the length of the slidingsuture 80 may be dependent on the surface roughness, compressibility andlubricity, such as from a lubricant, of the sliding suture 80, as wellas the tightness of the anchor 20 against the sliding suture 80.

Referring to FIGS. 20-27 and 34-40, there is shown a length of suture 10having a suture first end 11 and a suture second end 12 opposite thesuture first end 11. The suture 10 comprises a tubular braid structuredefining a suture wall 13 having a suture outer surface 14 and a lumen16 therethrough, as shown in FIG. 20.

A bulking suture 90 is placed over a portion of the suture 10, as shownin FIG. 22. The suture second end 12 is inserted into the lumen 16through an aperture in the suture wall 13 adjacent a bulking suturefirst end 91 of the bulking suture 90 so as to extend for apredetermined distance within the lumen 16, and exits the lumen 16though another aperture in the suture wall 13 adjacent a bulking suturesecond end 92 of the bulking suture 90, as shown in FIGS. 24-27. Thesuture first end 11 is inserted into the lumen 16 through an aperture inthe suture wall 13 so as to extend for a predetermined distance withinthe lumen 16 of the suture 10 and exits the lumen 16 though anotheraperture in the suture wall 13, as shown in FIG. 35-36. A sliding suture80 comprising a length of a second suture, is inserted into the lumen 16through the aperture in the suture wall 13 of the suture 10 so as toextend for a predetermined distance within the lumen 16 of the suture 10and exits the lumen 16 though another aperture in the suture wall 13 ofthe suture 10, as shown in FIGS. 34-35. Tension placed on the suturefirst end 11 and suture second end 12 causes a bunching of the suture 1where the suture first end 11 and suture second end 12 extends for apredetermined distance within the lumen 16 and about the bulking suturedefining an anchor 20, this bunching presenting a large profile so as towedge the anchor 20 into a pilot hole 72 in bone 70 which is resistantto pull-out, as shown in FIGS. 37-40. The sliding suture 80 is operableto slide within the anchor 20 along the length of the sliding suture 80.With the anchor 20 coupled into the bone 70, the suture first end 11 andsuture second end 12 may be used to engage tissue and hold it againstthe bone 70 for healing, such as, but not limited to, tendonreattachment.

Referring to FIGS. 20-27 and 34-40, an embodiment of a method of makinga soft suture anchor 4 comprises:

providing a length of suture 10 having a suture first end 11 and asuture second end 12 opposite the suture first end 11, the suture 10comprising a tubular braid structure defining a suture wall 13 having asuture outer surface 14 and a lumen 16 therethrough, as shown in FIG.20;

defining a first penetration point 31 and a second penetration point 32a predetermined distance from the first penetration point 31, the firstpenetration point 31 and second penetration point 32 are located apredetermined distance from the suture first end 11 and suture secondend 12, the first penetration point 31 and the second penetration point32 defining a passageway portion 34 therebetween, as shown in FIG. 23;

providing a lacing tool 40 comprising an elongated shaft 43 having ashaft first end 41 and a shaft second end 42, a handle 46 optionallyformed in the shaft second end 42, the shaft first end 41 formed into ahook 45, the shaft first end 41 further comprising a lever 48 pivotallycoupled to the shaft first end 41 adjacent the hook 45 operable to closethe hook 45 in a first position and to open the hook 45 in a secondposition, as shown in FIG. 21;

providing a length of bulking suture that is substantially the same orsmaller in length as the passageway portion 34 between the firstpenetration point and a second penetration point 32, the bulking sutureincluding a bulking suture first end 91 and a bulking suture second end92 opposite the bulking suture first end 91, the bulking suture 90comprising a tubular structure defining a bulking suture lumentherethrough, as shown in FIG. 21;

threading the suture second end 12 through the bulking suture lumen andadvancing the bulking suture to the passageway portion 34, as shown inFIG. 22;

in another embodiment, threading comprises: advancing the hook 45 of thelacing tool 40 through the bulking suture lumen such that the bulkingsuture is disposed on the shaft of the lacing tool 40 between the hook45 and the handle; placing the suture second end 12 into the hook 45 andclosing the lever 48; and pulling the hook 45 so as to pull the suturesecond end 12 into and through the bulking suture lumen and removing thelacing tool 40 from the bulking suture lumen, as shown in FIG. 21;

advancing the hook 45 of the lacing tool 40 from the suture outersurface 14 to the lumen 16 at the first penetration point 31 byadvancing the hook 45 through the strands of the braid without breakingthe strands;

advancing the hook 45 to the second penetration point 32 within thelumen 16;

advancing the hook 45 from the lumen 16 to the suture outer surface 14at the second penetration point 32 by advancing the hook 45 through thestrands of the braid without breaking the strands, a portion of theshaft 43 extending through the lumen 16 between the first penetrationpoint 31 and the second penetration point 32, as shown in FIG. 24;

placing the suture second end 12 into the hook 45 and closing the lever48, as shown in FIG. 25;

pulling the hook 45 so as to pull the suture second end 12 into thesecond penetration point 32, through the lumen 16 and out of the firstpenetration point 31 forming a first loop 51 and removing the lacingtool 40 from the suture 10, as shown in FIG. 26-27;

advancing the hook 45 of the lacing tool 40 from the suture outersurface 14 to the lumen 16 at the second penetration point 32;

advancing the hook 45 to the first penetration point 31 within the lumen16;

advancing the hook 45 from the lumen 16 to the suture outer surface 14at the first penetration point 31, a portion of the shaft 43 extendingthrough the lumen 16 between the second penetration point 32 and thefirst penetration point 31, as shown in FIG. 28;

placing the suture first end 11 into the hook 45 and closing the lever48, as shown in FIG. 28; and

pulling the hook 45 so as to pull the suture first end 11 into the firstpenetration point 31, through the lumen 16 and out of the secondpenetration point 32 forming a second loop 52 and removing the lacingtool 40 from the suture 10, wherein the first loop 51, the second loop52 and the passageway portion 34 define an anchor 20, advancing the hook45 of the lacing tool 40 from the suture outer surface 14 to the lumen16 at the first penetration point 31 by advancing the hook 45 throughthe strands of the braid without breaking the strands, as shown in FIG.29;

advancing the hook 45 through the second penetration point 32 and withinthe lumen 16;

advancing the hook 45 from the lumen 16 to the suture outer surface 14at the first penetration point 31 by advancing the hook 45 through thestrands of the braid without breaking the strands, a portion of theshaft 43 extending through the lumen 16 between the second penetrationpoint 32 and the first penetration point 31, as shown in FIG. 34;

providing a length of sliding suture 80 having a sliding suture firstend 81 and a sliding suture second end 82 opposite the sliding suturefirst end 81, as shown in FIG. 34;

placing the sliding suture first end 81 into the hook 45 and closing thelever 48, as shown in FIG. 35; and

pulling the hook 45 so as to pull the sliding suture first end 81 intothe first penetration point 31, through the lumen 16 and out of thesecond penetration point 32, removing the lacing tool 40 from the suture10, wherein the sliding suture 80 may slide relative to the anchor 20along the length of the sliding suture 80, as shown in FIG. 35 36.

Referring to FIGS. 39-40, an embodiment of a method for using a softsuture anchor 4 comprises: placing the anchor 20 into a pilot hole 72drilled into a bone 70 defining a base 73, as shown in FIG. 39; engaginga hold-down tool 74 to hold the anchor 20 at about the base 73 of thepilot hole 72, as shown in FIG. 39; and

putting tension on the suture first end 11 and the suture second end 12operable to reduce the size of the first loop 51 and the second loop 52and to cinch the bulking suture 90 and the passageway portion 34operable to engage the pilot hole 72, wherein the sliding suture 80 mayslide through the anchor 20 along the length of the sliding suture 80,as shown in FIG. 40.

The hold-down tool 74 is any suitable instrument that is operable tohold the anchor 20 in the pilot hole 72. The hold-down tool 74 maycomprise an elongated member with an end that may be received into thepilot hole 72.

It is appreciated that the method of forming the first loop 51 andsecond loop 52 may be repeated so as to form any number of first loops51 and second loops 52 suitable for a particular purpose. Limitingfactors for the number of first loops 51 and second loops 52 may be thesize of the lumen 16 or the size of the penetration holes at the firstpenetration point and the second penetration point 32.

It is appreciated that the size of the anchor may be dependent on thesuture diameter, the number of loops, the length of the bunching portionand the length, size and thickness of the bulking suture 90, among otherthings.

A longer passageway portion 34 will create a larger anchor profile ascompared with a smaller passageway portion 34 wherein the distancebetween the first penetration point 31 and second penetration point 32is smaller.

A longer or thicker bulking suture 90 will create a larger anchorprofile as compared with a shorter or thinner bulking suture 90.

The sliding suture 80 may be a monofilament or multi-filament twisted orbraided suture suitable for a particular purpose. The slidingcharacteristics of the sliding suture 80 along the length of the slidingsuture 80 may be dependent on the surface roughness, compressibility andlubricity, such as from a lubricant, of the sliding suture 80, as wellas the tightness of the anchor 20 against the sliding suture 80.

In accordance with an embodiment, the soft suture anchor comprises asuture having a tubular braid construction defining a lumentherethrough. The suture defines a suture first end, a suture second endopposite the suture first end, and an anchor between the suture firstend and the suture second end. The anchor comprises the sutureconfigured into one or more loops wherein causing tension between theanchor and the suture first end and the suture second end causes the oneor more loops to cinch and present a profile operable to wedge theanchor into a pilot hole which is resistant to pull-out.

In another embodiment, the soft suture anchor further comprises at leasta portion of each of the one or more loops extends within the lumen at abunching portion. The bunching portion is that portion of the suturebetween wherein the one or more loops enters the lumen and exits thelumen, wherein causing tension between the anchor and the suture firstend and the suture second end causes the one or more loops to cinch andbunch the bunching portion so as to present a profile operable to wedgethe anchor into a pilot hole which is resistant to pull-out.

In another embodiment, the soft suture anchor further comprises a secondsuture having a tubular braid construction defining a second lumentherethrough, the second suture advanced over the suture via the secondlumen and positioned at the bunching portion, wherein causing tensionbetween the anchor and the suture first end and the suture second endcauses the one or more loops to cinch and bunch the bunching portion andsecond suture so as to present a profile operable to wedge the anchorinto a pilot hole which is resistant to pull-out.

In another embodiment, the soft suture anchor further comprises a thirdsuture, the third suture advanced through the lumen at the bunchingportion, wherein causing tension between the anchor and the suture firstend and the suture second end causes the one or more loops to cinch andbunch the bunching portion so as to present a profile operable to wedgethe anchor into a pilot hole which is resistant to pull-out whileallowing the third suture to slide relative to the anchor.

In other embodiments, the soft suture anchor further comprisescombinations of the elements described above.

Per the requirements of the application, the suture can be composed ofany suitable material which can be processed to prepare a filamentarystrand. For example, the suture may be composed of an absorbable ornonabsorbable material, and it can be configured as a braid, or ifdesired, as a monofilament. An example of a nonabsorbable material ispolyester and UHMWPE. Examples of absorbable materials are derived fromhomopolymers and copolymers of glycolide, lactide, ε-caprolactone,p-dioxanone, and trimethylene, polybutylene succinate, polycaprolatone(PCL), polyglycolic acid (PGA), and polylactic acid (PLA). Bioabsorbable sutures may be used in procedures, such as, but not limitedto, that require temporary fixation of tissue to bone during the healingprocess but is not required after healing.

The soft suture anchors 1, 2, 3, 4 provided in embodiments above may beprovided to the physician in kit form with various sutures 10 and alacing tool 40 where the physician may make an anchor 20 of a particularsize and configuration suitable for a particular purpose.

The soft suture anchor may be provided to the physician in its assembledform and in various anchor sizes.

The soft suture anchor may be provided to the physician mounted to ahold-down rod used to insert and hold the anchor at the base of thepilot hole during insertion and deployment.

A lacing tool 40 is described above as having a lever 48 that ispivotally coupled to the shaft and opens the hook-shaped distal portionin a first position and closes the hook shaped distal portion in asecond position. In an alternative embodiment, the leaver is replaced bya latch that is slidably coupled to the shaft and may be advanced awayfrom the hook-shaped distal portion in a first position to open, andadvanced over the hook-shaped distal portion in a second position toclose. It is appreciated that there are many tools which may provide thefunctionality of the lacing tool 40 as described, and the examplesprovided above are non-limiting.

By way of example of the use of embodiments of soft suture anchorsprovided herein, a Bankart repair is discussed below. It is understoodthat this is only an example and the use of the soft suture anchors isnot to be limited thereto.

For treatment of a Bankart lesion wherein there is detachment of theinferior half of the anterior glenoid labrum, embodiments of the softsuture anchors provided herein replace the metal bone suture anchors andsutures commonly used for this procedure.

Once the glenoid rim has been prepared, three pilot holes are made onthe glenoid rim at the osteochondral junction, or just on the jointsurface. These drill holes will each accommodate one of the soft sutureanchors provided herein. The soft suture anchors should be distributedalong the glenoid rim to allow the entire detached capsule to besecurely fixed to bone. The lower anchor should be introduced as low aspossible, and the remaining two about 1 to 1.5 cm apart.

The anchor is placed into the pilot holes that were drilled into thebone. A tool is used to hold the anchor at about the base of the pilothole while simultaneous tension is made on the suture first end andsuture second end operable to cinch the bunching portion so as to causethe anchor to present a profile so as to wedge the anchor into the pilothole which is resistant to pull-out,

One of the suture first end and suture second end is taken inside outthrough the medial rim of the detached capsule of labral tissue. Thisdistal placement of the sutures in the capsule allows a slight proximalshift of the capsule during the repair in cases with inferior laxity.With all three sutures passed through the capsule, a trial reduction canbe carried out. The surgeon reduces the capsule onto the glenoid rim bytying the other of the suture first end and suture second end to therespective other suture, thus repairing the anterior capsule onto theglenoid rim. The two strands from adjacent anchors are tied together. Bytying single strands of sutures from adjacent anchors together, a stronghorizontal mattress suture line is created on the glenoid rim holdingthe capsule firmly down onto the bone. The knots are completed, thuscompletely obliterating the glenoid rim defect and, if desired, shiftingthe inferior capsule proximally (or in a cephalad direction).

The soft suture anchor provided in embodiments above may be used in manysurgical procedures, including, but not limited to: Shoulders—Labralrepair and rotator cuff repair; Foot and ankle—Medial/lateral repair andreconstruction, Mid- and forefoot repair, Hallux valgus reconstruction,Metatarsal ligament/tendon repair or reconstruction, and Achilles TendonRepair; and Hand and Wrist Indications—Collateral ligament repair,Scapholunate ligament reconstruction, tendon transfers in phalanx, andVolar plate reconstruction.

Suture Tape Anchor

FIGS. 55-58 are side views of an embodiment of a soft suture tape anchorassembly 5 including a deployed anchor 22 with suture ends 111, 112,121, 122 extending therefrom.

Referring to FIGS. 41-61, a soft suture tape anchor assembly 5 comprisesa length of suture tape 100 having a suture tape first end 101 and asuture tape second end 102 opposite the suture tape first end 101, asshown in FIG. 41. The suture tape 100 comprises a weave including aplurality of warp suture strands 103 woven in a warp configuration(where the strands are substantially parallel to the longitudinalcentral axis X) and weft suture strands (not shown, where the strandsare substantially perpendicular to the longitudinal axis X) woven in aweft configuration. The ends of one or more warp suture strands 103 aredeconstructed from the weave of the suture tape 100, and hereinafterreferred to as deconstructed suture strands 108, leaving an alternativevariant of an anchor in the form of a woven anchor 20′ (FIGS. 45 and46), of the warp suture strands 103 remaining in the weave, as shown inFIGS. 42 46. The deconstructed suture strands 108 comprise adeconstructed suture strand first end 104 and a deconstructed suturestrand second end 109 opposite from the deconstructed suture strandfirst end 104. The deconstructed suture strand first end 104 and thedeconstructed suture strand second end 109 of the one or moredeconstructed suture strands 108 being rewoven in retrograde (oppositedirection of the original direction of the strand) direction into theanchor 20′ to emerge from a center location 140 of the anchor or anchor20′, as shown in FIGS. 47-55, operable such that tension on thedeconstructed suture strand first end 104 and the deconstructed suturestrand second end 109 of the one or more deconstructed suture strands108 causes the anchor 20′ to cinch and/or bunch together and present aprofile such that the deployed anchor 22 engages a pilot hole 72 in bone70 which is resistant to pullout.

In accordance with embodiments, the suture tape 100 is made entirely ofbiocompatible suture material, such as, but not limited to UHMWPE(ultra-high molecular weight polyethylene), polyester, mixtures thereof,and bio absorbable compounds and mixtures such as, but not limited topolybutylene succinate, polycaprolatone (PCL), polyglycolic acid (PGA),and polylactic acid (PLA).

In accordance with an embodiment, one or more of the warp strands may beUHMWPE with the remainder being polyester, by way of example. Inaccordance with an embodiment, one or more individual suture strands maybe woven in the warp orientation and used as the suture strands thatextend from the anchor, in a secondary process after the production of asuture tape. In accordance with an embodiment, one or more individualUHMWPE strands may be weaved in the warp orientation and used as thesuture strands that extend from the anchor, in a secondary process afterthe production of a suture tape.

Referring to FIGS. 41-61, there is shown a length of suture tape 100having a suture tape first end 101 and a suture tape second end 102opposite the suture tape first end 101, as shown in FIG. 41. The suturetape 100 comprises a plurality of suture strands 103 woven in a warp andweft configuration defining a weave. In this embodiment, the ends of oneor more warp suture strands 103 are deconstructed from the weave of thesuture tape 100, and hereinafter referred to as deconstructed suturestrands 108, defining an anchor 20′ comprising a portion of the warpsuture strands remaining in the weave, as shown in FIGS. 42-46. Thedeconstructed suture strands 108 comprise a deconstructed suture strandfirst end 104 and a deconstructed suture strand second end 109 oppositefrom the deconstructed suture strand first end 104. The deconstructedsuture strand first end 104 and the deconstructed suture strand secondend 109 are subsequently rewoven in retrograde direction into the anchor20′ to emerge from a center location 140 of the anchor 20′, as shown inFIG. 47-55. The anchor 20′ may be disposed in a pilot hole 72, such as apilot hole 72 resulting from drilling into bone 70, as shown in FIG. 57.Tension on the deconstructed suture strand first end 104 and thedeconstructed suture strand second end 109 causes the anchor 20′ tocinch and/or bunch together and present a profile so as to wedge thedeployed anchor 22 into the pilot hole 72 which is resistant topull-out, as shown in FIG. 58. With the deployed anchor 22 anchored intothe bone 70, the deconstructed suture strand first end 104 and thedeconstructed suture strand second end 109 may be used to engage tissueand hold it against the bone 70 for, such as, but not limited to, tendonreattachment.

Referring to FIGS. 41-61, an embodiment of a method for making a softsuture anchor assembly 5 comprises:

providing a length of suture tape 100 comprising a warp and weft weavestructure defining a tape first side 105 and a tape second side 106opposite the tape first side 105 and a tape first end 101 and a tapesecond end 102 opposite the tape first end 101, as shown in FIG. 41, thesuture tape 100 having a plurality of warp suture strands 103 woven aswarp in the warp and weft configuration, each warp suture strand 103including a warp suture first end 104 and a warp suture second end 109opposite the warp suture first end 104, the suture tape 100 defining acentral longitudinal axis X and a transverse axis Y perpendicular to thecentral longitudinal axis X, as shown in FIG. 41;

defining one of the warp suture strands 103 as a first deconstructedsuture strand 110, the first deconstructed suture strand 110 comprisinga first deconstructed suture strand first end 111 and a firstdeconstructed suture strand second end 112 opposite from the firstdeconstructed suture strand first end 111,

defining a first deconstruction point 131 and a second deconstructionpoint 132 a predetermined distance from the first deconstruction point131, the first deconstruction point 131 located adjacent the firstdeconstructed suture first end 111 of the first deconstructed suturestrand 110 and the second deconstructed point 132 located adjacent thefirst deconstructed suture second end 112 of the first deconstructedsuture strand 110, the first deconstructed suture strand 110 beingspaced a predetermined distance from the central longitudinal axis X, asshown in FIG. 42-45;

defining another one of the warp suture strands 103 as a seconddeconstructed suture strand 120, the second deconstructed suture strand120 comprising a second deconstructed suture strand first end 121 and asecond deconstructed suture strand second end 122 opposite from thesecond deconstructed suture strand first end 121,

defining a third deconstruction point 133 and a fourth deconstructionpoint 134 a predetermined distance from the third deconstruction point133, the third deconstruction point 133 located adjacent the seconddeconstructed suture first end 121 of the second deconstructed suturestrand 120 and the fourth deconstructed point 134 located adjacent thesecond deconstructed suture strand second end 122 of the seconddeconstructed suture strand 120, the second deconstructed suture strand120 being spaced a predetermined distance from the central longitudinalaxis X and opposite from the central longitudinal axis X from the firstdeconstructed suture strand 110,

the first deconstruction point 131 and the third deconstruction point133 being substantially aligned along a first transverse axis Y1 that issubstantially perpendicular to the central longitudinal axis X, thesecond deconstruction point 132 and the fourth deconstruction point 134being substantially aligned along a second transverse axis Y2 that issubstantially perpendicular to the central longitudinal axis X, thesuture tape 100 defining an anchor 20′ between the first transverse axisY1 and second transverse axis Y2, as shown in FIGS. 42-45;

withdrawing the first deconstructed suture strand first end 111 and thefirst deconstructed suture strand second end 112 of the firstdeconstructed suture strand 110 from the weft, as shown in FIGS. 44-45;

withdrawing the second deconstructed suture strand first end 121 and thesecond deconstructed suture strand second end 122 of the seconddeconstructed suture strand 120 from the weft, as shown in FIGS. 45-46;

trimming the tape first end 101 and tape second end 102 adjacent to thefirst transverse axis Y1 and second transverse axis Y2 and opposite fromthe anchor 20′, as shown in FIGS. 46-47;

providing a lacing tool 40 comprising an elongated shaft 43 having ashaft first end 41 and a shaft second end 42, a handle 46 optionallyformed in the shaft second end 42, the shaft first end 41 formed into ahook 45, the shaft first end 41 further comprising a lever 48 pivotallycoupled to the shaft first end 41 adjacent the hook 45 operable to closethe hook 45 in a first position and to open the hook 45 in a secondposition, as shown in FIG. 48;

engaging a first center location 141 of the anchor 20′ substantiallyequidistant from the first transverse axis Y1 and second transverse axisY2 with the hook 45 of the lacing tool 40 weaving one or more timesthrough the anchor 20′ as if a warp strand, terminating the weaving atabout the first transverse axis Y1, as shown in FIG. 48;

placing the second deconstructed suture strand first end 121 into thehook 45 and closing the lever 48, as shown in FIG. 48;

pulling the hook 45 so as to pull the second deconstructed suture strandfirst end 121 through the weave of the anchor 20′, removing the lacingtool 40 from the suture tape 100 such that the second deconstructedsuture strand first end 121 extends out of the first center location141, as shown in FIG. 49;

engaging a second center location 142 of the anchor 20′ substantiallyequidistant from the first transverse axis Y1 and second transverse axisY2 and adjacent to the first center location 141 with the hook 45 of thelacing tool 40 weaving one or more times through the anchor 20′ as if awarp strand, terminating the weaving at about the first transverse axisY1, as shown in FIG. 50;

placing the first deconstructed suture strand first end 111 into thehook 45 and closing the lever 48, as shown in FIG. 50;

pulling the hook 45 so as to pull the first deconstructed suture strandfirst end 111 through the weave of the anchor 20′, removing the lacingtool 40 from the suture tape 100 such that the first deconstructedsuture strand first end 111 extends out of the second center location142, as shown in FIG. 51;

engaging a third center location 143 of the anchor 20′ substantiallyequidistant from the first transverse axis Y1 and second transverse axisY2 with the hook 45 of the lacing tool 40 weaving one or more timesthrough the anchor 20′ as if a warp strand, terminating the weaving atabout the second transverse axis Y2, as shown in FIG. 52 placing thesecond deconstructed suture strand second end 122 into the hook 45 andclosing the lever 48, as shown in FIG. 52;

pulling the hook 45 so as to pull the second deconstructed suture strandsecond end 122 through the weave of the anchor 20′, removing the lacingtool 40 from the suture tape 100 such that the second deconstructedsuture strand second end 122 extends out of the third center location143, as shown in FIG. 53;

engaging a fourth center location 144 of the anchor 20′ substantiallyequidistant from the first transverse axis Y1 and second transverse axisY2 and adjacent to the third center location 143 with the hook 45 of thelacing tool 40 weaving one or more times through the anchor 20′ as if awarp strand, terminating the weaving at about the second transverse axisY2, as shown in FIG. 53; and

placing the first deconstructed suture strand second end 112 into thehook 45 and closing the lever 48, as shown in FIG. 53;

pulling the hook 45 so as to pull the first deconstructed suture strandsecond end 112 through the weave of the anchor 20′, removing the lacingtool 40 from the suture tape 100 such that the first deconstructedsuture strand second end 112 extends out of the fourth center location144 permitting a deployed anchor 22, as shown in FIG. 56.

An embodiment of a method for using a soft suture anchor assembly 5comprises:

placing the deployed anchor 22 into a pilot hole 72 drilled into a bone70, the pilot hole 72 defining a base 73, as shown in FIG. 57;

engaging an insertion and retention tool 74 to hold the anchor 20′ atabout the base 73; and

putting tension on the first deconstructed suture strand first end 111,first deconstructed suture strand second end 112, second deconstructedsuture strand first end 121, and second deconstructed suture strandsecond end 122 operable to cinch and/or bunch the anchor 20′ such thatthe deployed anchor 22 engages the pilot hole 72, as shown in FIGS.57-58.

The tool 74 may be any suitable instrument that is operable to pushand/or hold the anchor 20 in the pilot hole 72. The tool 74 may comprisean elongated member with an end that may be received into the pilot hole72.

It is appreciated that wherein the deployed anchor 22 may be engagedpredominantly by bunching, as defined below, the tool 74 may be used topush the anchor 24 to about the base 73 and then removed prior toputting tension on the first deconstructed suture strand first end 111,first deconstructed suture strand second end 112, second deconstructedsuture strand first end 121, and second deconstructed suture strandsecond end 122 operable to cinch and/or bunch the anchor 20′ such thatthe deployed anchor 22 engages the pilot hole 72;

It is appreciated that the first center location 141, second centerlocation 142, third center location 143, and fourth center location 144may be co-located at one center location 140 such that the first andsecond deconstructed suture strand ends 111, 112, 121, 122 extend fromthe same center location 140 of the anchor 20′. Skilled persons willreadily recognize, further in view of FIG. 57, that center location 140is also a “hold region,” that is, a region that is optimally held inplace as ends 121 and 122 are pulled to set anchor 20 into surroundingbone.

An embodiment of a method for using a soft suture anchor assembly 5further comprising:

removing one of the first deconstructed suture strand 110 and seconddeconstructed suture strand 120 from the deployed anchor 22 by puttingtension on one of the first and second ends 111,112,121, 122 allowingone of the first deconstructed suture strand 110 and seconddeconstructed suture strand 120 to slide out of the anchor 20′, as shownin FIGS. 59-61.

It is appreciated that the size of the deployed anchor 22 may bedependent, in-part, on the suture tape width and the length of theanchor 20′. A longer anchor 20′ will create a larger anchor profile ascompared with a smaller anchor 20′ wherein the distance between thefirst penetration point 131 and second penetration point 132 defines thelength of the anchor 20′.

It is appreciated that one or more warp suture strands 103 may bedeconstructed from the suture tape 100 as described above so as toprovide a desired number of deconstructed suture strand ends forsecuring tissue and the like. In the above embodiment of the soft sutureanchor, two deconstructed strands is shown by way of example. It isunderstood and appreciated that an embodiment of the soft suture anchormay comprise one deconstructed suture strand, wherein other embodimentsof the soft suture anchor may comprise a plurality of deconstructedsuture strands.

Cinching is defined herein as a squeezing together of the anchor 20′substantially due to a slippage or movement of a deconstructed suturestrand with respect to other suture strands such that the anchor 20′ isdrawn together. For example, referring to the embodiment above, tensionon the first deconstructed suture strand first end 111 and on the firstdeconstructed suture strand second end 112 may cause the firstdeconstructed suture strand 103 to slip relative to the other suturestrands in the anchor 20′ operable to squeeze together the anchor 20′towards the center location 140 without the requirement of cooperativeengagement with another structure, such as, whether or not the deployedanchor 22 is in a pilot hole 72.

Bunching is defined as a squeezing together of the anchor 20′substantially due to other than a slippage or movement of adeconstructed suture strand with respect to other suture strands. By wayof example, bunching may be caused by the operative frictionalengagement of the anchor 20′ with another structure, such as with thebore of the pilot hole 72. For example, referring to the embodimentsabove, tension on the first deconstructed suture strand first end 111and on the first deconstructed suture strand second end 112 may causethe anchor 20′ to drag against the bore of the pilot hole 72 so as tocause the anchor 20′ to squeeze together and wedge against the bore ofthe pilot hole 72 sufficient to prevent pullout of the deployed anchor22 from the pilot hole 72.

It is understood that in certain embodiments, the predominate mechanismfor anchoring the deployed anchor 22 into the pilot hole 72 is cinching,bunching, or a combination of cinching and bunching. It is understoodthat the depth of the pilot hole 72 may be less where cinching is thepredominant squeezing mechanism on the anchor 20′ as compared tobunching where dragging along the bore of the pilot hole 72 may berequired to affect the squeezing of the deployed anchor 22.

In accordance with embodiments, the first deconstructed suture strand110 and second deconstructed suture strand 120 may move relative to theanchor 20′ when tension on one or more of the first and second ends111,112,121, 122 is applied such that the predominate mechanism foranchoring the deployed anchor 22 into the pilot hole 72 is cinching.

In accordance with other embodiments, the first deconstructed suturestrand 110 and second deconstructed suture strand 120 may not moverelative to the anchor 20′ when tension on one or more of the first andsecond ends 111,112,121, 122 is applied such that the predominatemechanism for anchoring the deployed anchor 22 into the pilot hole 72 isbunching.

In accordance with yet other embodiments, the first deconstructed suturestrand 110 and second deconstructed suture strand 120 may move and maynot move relative to the anchor 20′ when tension on one or more of thefirst and second ends 111,112,121, 122 is applied such that thepredominate mechanism for anchoring the deployed anchor 22 into thepilot hole 72 is a combination of cinching and bunching.

Wavy Tape Suture Anchor

FIGS. 68-71 are side views of an embodiment of a soft suture anchor 6including an anchor 24 with suture ends 211, 212 extending therefrom.

Referring to FIGS. 62-71, a soft suture anchor 6 comprises a length ofwavy suture tape 200 having a suture tape first end 201 and a suturetape second end 202 opposite the suture tape first end 201, as shown inFIG. 62. The wavy suture tape 200 comprises a plurality of warp suturestrands 203 woven in a warp configuration (where the strands aregenerally parallel to but having a generally sinusoidal path relative tothe longitudinal central axis X) and weft suture strands (not shown,where the strands are substantially perpendicular to the longitudinalaxis X) woven in a weft configuration.

The ends of one or more warp suture strands 203 are deconstructed fromthe weave of the suture tape 200, and hereinafter referred to as adeconstructed suture strand 208, leaving an anchor 20′ of the warpsuture strands 203 remaining in the weave, as shown in FIGS. 63-67,defining in part the anchor 24, as shown in FIGS. 68-71. Thedeconstructed suture strand 208 comprise a deconstructed suture strandfirst end 211 and a deconstructed suture strand second end 212 oppositefrom the deconstructed suture strand first end 211. Tension on thedeconstructed suture strand first end 211 and the deconstructed suturestrand second end 212 of the one or more deconstructed suture strands208 causes the anchor 20′ to cinch and/or bunch together to present aprofile such that the anchor 20′ may engage a pilot hole 72 in bone 70which is resistant to pull-out.

In accordance with embodiments, the wavy suture tape 200 is made byapplying differential tension across elements of a weaving machine. Thestructure of the wavy suture tape may be produced, among other ways, byvarying the tension between adjacent warp or weft threads. This tensionvariation may induce a generally sinusoidal or undulating pattern in thewarp. The frequency and amplitude of the undulating pattern may becontrolled by adjusting parameters on the weaving machine.

The wavy tape 200 may present a larger or more three-dimensional profileas compared to a straight suture tape, such as suture tape 100 presentedabove, and as such, may better engage and better resist pullout from apilot hole 72.

In accordance with embodiments, the wavy suture tape is made entirely ofbiocompatible suture material, such as, but not limited to UHMWPE(ultra-high molecular weight polyethylene), polyester, mixtures thereof,and bio absorbable compounds and mixtures such as, but not limited topolybutylene succinate, polycaprolatone (PCL), polyglycolic acid (PGA),and polylactic acid (PLA). In accordance with an embodiment, one or moreof the warp strands may be UHMWPE with the remainder being polyester, byway of example. In accordance with an embodiment, one or more individualsuture strands may be woven in the warp orientation and used as thesuture strands that extend from the anchor, in a secondary process afterthe production of a suture tape. In accordance with an embodiment, oneor more individual UHMWPE strands may be weaved in the warp orientationand used as the suture strands that extend from the anchor, in asecondary process after the production of a suture tape.

Referring to FIGS. 62-71, there is shown a length of wavy suture tape200 having a suture tape first end 201 and a suture tape second end 202opposite the suture tape first end 201, as shown in FIG. 62. The wavysuture tape 200 comprises a plurality of suture strands 203 woven in awarp configuration, where the strands are generally parallel to buthaving a generally sinusoidal path relative to the longitudinal centralaxis X.

In this embodiment, the ends of one or more warp suture strands 203 aredeconstructed from the weave of the suture tape 200, and hereinafterreferred to as deconstructed suture strands 208, defining an anchor 20′comprising a portion of the warp suture strands remaining in the weave,as shown in FIGS. 63-67. The deconstructed suture strands 208 comprise adeconstructed suture strand first end 211 and a deconstructed suturestrand second end 212 opposite from the deconstructed suture strandfirst end 211. The anchor 20′, defining in-part an anchor 24, may bedisposed in a pilot hole 72, such as a pilot hole 72 resulting fromdrilling into bone 70, as shown in FIG. 69. Tension on the deconstructedsuture strand first end 211 and the deconstructed suture strand secondend 212 causes the anchor 20′ to cinch and/or bunch and present aprofile so as to wedge the anchor 24 into the pilot hole 72 which isresistant to pull-out, as shown in FIG. 70-71. With the anchor 24anchored into the bone 70, the deconstructed suture strand first end 211and the deconstructed suture strand second end 212 may be used, forexample, to engage tissue and hold it against the bone 70 for healing,such as, but not limited to, tendon reattachment.

Referring to FIGS. 62-71, an embodiment of a method for making a softsuture tape anchor 6 comprises:

providing a length of wavy suture tape 200 comprising a warp and weftweave structure defining a tape first side 105 and a tape second side106 opposite the tape first side 105 and a tape first end 201 and a tapesecond end 202 opposite the tape first end 201, as shown in FIG. 62, thewavy suture tape 200 having a plurality of warp suture strands 203 wovenas warp in the warp and weft configuration, each warp suture strand 203including a warp suture first end 204 and a warp suture second end 209opposite the warp suture first end 204, the wavy suture tape 200defining a central longitudinal axis X and a transverse axis Yperpendicular to the central longitudinal axis X, as shown in FIG. 62;

defining one of the warp suture strands 203 as a deconstructed suturestrand 208, the deconstructed suture strand 208 comprising adeconstructed suture strand first end 211 and a deconstructed suturestrand second end 212 opposite from the deconstructed suture strandfirst end 211,

defining a first deconstruction point 131 and a second deconstructionpoint 132 a predetermined distance from the first deconstruction point131, the first deconstruction point 131 located adjacent thedeconstructed suture first end 211 of the deconstructed suture strand208 and the second deconstructed point 132 located adjacent thedeconstructed suture second end 212 of the deconstructed suture strand208, as shown in FIG. 63-65;

withdrawing the deconstructed suture strand first end 211 and thedeconstructed suture strand second end 212 of the deconstructed suturestrand 208 from the weft, of the wavy suture tape 200, as shown in FIGS.63-64;

trimming the tape first end 201 and tape second end 202 adjacent to afirst transverse axis Y1 and a second transverse axis Y2 and oppositefrom the anchor 20′, as shown in FIG. 66, defining an anchor 24, asshown in FIG. 67.

An embodiment of a method for using a soft suture tape anchor 6comprises:

placing the anchor 24 into a pilot hole 72 drilled into a bone 70, thepilot hole 72 defining a base 73, as shown in FIG. 69;

engaging a tool 74 to push the anchor 24 to about the base 73; and

putting tension on the warp suture first end 211 and warp suture secondend 212 operable to cinch and/or bunch the anchor 20′ such that theanchor 24 engages the pilot hole 72, as shown in FIGS. 69-71.

The tool 74 is any suitable instrument that is operable to push theanchor 24 in the pilot hole 72. The tool 74 may comprise an elongatedmember with an end that may be received into the pilot hole 72.

It is appreciated that the size of the anchor 24 may be dependent,in-part, on the suture tape width and the length of the anchor 20′. Alonger anchor 20′ will create a larger anchor profile as compared with asmaller anchor 20′ wherein the distance between the first penetrationpoint 131 and second penetration point 132 defines the length of theanchor 20′.

It is appreciated that more than one warp suture strand 203 may bedeconstructed from the wavy suture tape 200 as described above so as toprovide additional suture ends for securing tissue and the like.

The above embodiment is described as the suture tape comprising a weaveconstruction. It is understood and appreciated that other constructionsare suitable for the particular purpose. By way of example, the suturetape may comprise a flat braid of suture strands. Regarding a braid, oneor more of the suture strands that are braided together is identified asa deconstructed suture strand with the embodiments comprising a braidbeing practiced substantially the same as for the embodiments comprisinga weave.

Skilled persons will readily recognized that the bunching portionvariants 34 and 20′ may each be termed an “anchor” that has anundeployed state, in the form of a ribbon or sheet of flexible material,as shown in FIGS. 56 and 57, and that may be compacted into a deployedstate, above termed “deployed anchor 22” as shown in FIG. 58, by pullingon deconstructed strands 108, 110, 111, 121 and 122 which may be termed“deployment strands.” It may further be noted that the deploymentstrands 108 are engaged to the first end 101 and second end 102 ofbunching portion (which may also be termed, “the anchor in itsundeployed state”) 34 by being looped around the ends 101, 102 (whichform the periphery of the anchor or anchor 34; more specifically end 101is a first peripheral location and end 102 is a second peripherallocation, opposed to the first peripheral location), with both ends ofeach deployment strand 108, 110, 111, 121 and 122 threaded through andexiting the anchor or anchor 20′ at a central location 140.

While the invention has been described in connection with specificembodiments thereof, it will be understood that it is capable of furthermodification, and this application is intended to cover any variations,uses, or adaptations of the invention following, in general, theprinciples of the invention and including such departures from thepresent disclosure as come within known or customary practice in the artto which the invention pertains and as may be applied to the essentialfeatures hereinbefore set forth, and as fall within the scope of theinvention and the limits of the appended claims.

The invention claimed is:
 1. A suture anchor assembly, adapted to beattached to a bone, comprising: (a) an anchor, which has an undeployedstate in which it is soft and flexible, and which can be deployed into adeployed state which is compacted and hard, relative to said undeployedstate, and defining a central hold region, where said anchor isoptimally held as said anchor is deployed, portions of said anchorextending laterally on both sides from said central hold region; (b) oneor more deployment strands engaged into said anchor and extending out ofsaid anchor, and wherein, when said anchor is in said undeployed state,holding said anchor in place at said central hold region and pulling onsaid one or more deployment strands compacts said anchor into saiddeployed state by pulling said portions of said anchor extendinglaterally on both sides into a ball at said central hold region; and (c)wherein said anchor in said undeployed state comprises a strand ofbraided material and wherein a portion of said strand of braidedmaterial is expanded to define a central lumen and wherein a firstpenetration point and a second penetration point, displaced along thelength of said braided material from said first penetration point, isformed in said strand of braided material and said strand of braidedmaterial extends through said first penetration point into said lumen,extends through said lumen along the length of said braided material,and extends out of said second penetration point, out of said lumen, andextends in a loop, and once again extends through said first penetrationpoint into said lumen and out of said second penetration point, out ofsaid lumen, so that two lengths of said strand of braided materialextend through said lumen of said strand of braided material along thelength of said braided material, thereby forming a double loop andwherein said strand of braided material has a first end portion and asecond end portion, which form said one or more deployment strands andwherein said lumen between said first penetration point and said secondpenetration point forms said central hold region; and (d) whereby saidanchor can be introduced into a hole in bone and held in place at saidhold region, as it is transformed into said deployed state by pulling onsaid one or more deployment strands, thereby causing said portions ofsaid anchor extending laterally on both sides from said central holdregion to collapse toward said central hold region, thereby anchoringsaid anchor in said hole.
 2. The suture anchor assembly of claim 1,wherein said strand of braided material is a first strand of braidedmaterial, and a second strand of braided material is threaded throughsaid first penetration point, through the lumen and through said secondpenetration point, so that said anchor and said second strand of braidedmaterial are in sliding engagement relative to each other.
 3. The sutureassembly of claim 1, wherein said strand of braided material is a firststrand of braided material, and a second strand of braided material isexpanded to form a lumen and is fit about said portion of said firstsaid strand of braided material that is expanded to define a centrallumen, said second strand of braided material thereby providingadditional bulk for said anchor.
 4. The suture anchor assembly of claim3, wherein said anchor is woven out of strands that are of the samematerial and construction as said one or more deployment strands.
 5. Thesuture anchor assembly of claim 3, wherein at least one of said one ormore deployment strands is a suture strand.
 6. The suture anchorassembly of claim 1, wherein said anchor includes tape having aperiphery and a central location and wherein each of said one or moredeployment strands are engaged to said periphery, and wherein said oneor more deployment strands exit said anchor at said central location,which is the central hold region, of said anchor, so that when saidanchor is held at said central hold region and said one or moredeployment strands are pulled, said periphery is pulled toward saidcentral location of said anchor, causing said anchor to compact into itsdeployed state.
 7. The suture anchor of claim 6, wherein said tape iswoven tape.
 8. The suture anchor of claim 7, wherein said woven tape iswoven of suture material.
 9. The suture anchor of claim 7, wherein saidone or more deployment strands are woven into said woven tape, passingthrough the periphery in a weave, and extending out through a centralportion.
 10. A method of attaching a suture to a bone, comprising: (a)providing an anchor, which has an undeployed state in which it is softand flexible, and which can be deployed into a deployed state which iscompacted and hard, relative to said undeployed state, and defining acentral hold region, where said anchor is optimally held as said anchoris deployed; and one or more deployment strands engaged into said anchorand extending out of said anchor, and wherein, when said anchor is insaid undeployed state, holding said anchor at said central hold regionand pulling on said one or more deployment strands compacts said anchorinto said deployed state; and (b) creating a pilot hole in said bone;(c) providing an insertion tool sized to push said suture into saidpilot hole; (d) placing said central hold region of said anchor ontosaid insertion tool and using said insertion tool to push said centralhold region of said anchor into said pilot hole, portions of said anchorextending laterally from said insertion tool and using a portion of saidinsertion tool that is introduced into and remains inside said pilothole as said anchor is deployed, to hold said central hold region ofsaid anchor in place inside said pilot hole, as said anchor istransformed into said deployed state by pulling on said one or moredeployment strands, causing said portions of said anchor extendinglaterally on both sides from said central hold region to collapse towardsaid central hold region, thereby entering said deployed state andthereby anchoring said anchor in said hole.
 11. The method of claim 10,wherein said anchor in said undeployed state comprises a first strand ofbraided material and wherein a portion of said first strand of braidedmaterial is expanded to define a central lumen and wherein a firstpenetration point and a second penetration point is formed in said firstsaid strand of braided material and said first said strand of braidedmaterial extends through said first penetration point into said lumenand out of said second penetration point, out of said lumen, and extendsin a loop, and once again extends through said first penetration pointinto said lumen and out of said second penetration point, out of saidlumen, so that two lengths of said first strand extend through saidfirst strand, thereby forming a double loop and wherein said firststrand has a first end portion and a second end portion, which form saidone or more deployment strands and wherein said lumen between said firstpenetration point and said second penetration forms said central holdregion, where said anchor is held in place during deployment, andwherein when said anchor is deployed, said double loop collapses into ahard ball, thereby setting said anchor.
 12. The method of claim 11,wherein a second strand of braided material is threaded through saidfirst penetration point, through the lumen and through said secondpenetration point, so that said anchor and said second strand of braidedmaterial are in sliding engagement relative to each other, before saidanchor is deployed.
 13. The method of claim 11, wherein a second strandof braided material is expanded to form a lumen and is fit about saidportion of said first strand of braided material that is expanded todefine a central lumen, said second strand of braided material therebyproviding additional bulk for said anchor.
 14. The method of claim 10,wherein said anchor is woven out of strands that are of the samematerial and construction as said one or more deployment strands. 15.The method of claim 10, wherein at least one of said one or moredeployment strands is a suture strand.
 16. The method of claim 10,wherein said anchor, in said undeployed state, includes tape having aperiphery and a central location and wherein each of said one or moredeployment strands are engaged to said periphery, and wherein said oneor more deployment strands exit said sheet at said central location,which is the central hold region of said anchor, so that when saidanchor is held at said central hold region and said one or moredeployment strands are pulled, said periphery is pulled toward saidcentral location of said anchor, causing said anchor to compact into itsdeployed state.
 17. The method of claim 16, wherein said tape is woventape.
 18. The method of claim 17, wherein said woven tape is woven ofsuture material.
 19. The method of claim 17, wherein said one or moredeployment strands are woven into said woven tape, passing through theperiphery in a weave, and extending out through a central portion.